While HCQ is used to prevent or treat malaria, remdesivir is sold as an antiviral drug.
The researchers from Oslo University Hospital and colleagues randomly assigned 181 hospitalised patients in 23 hospitals in Norway to receive remdesivir, HCQ, or standard of care.
The study, published in the journal Annals of Internal Medicine, evaluated the effects of the two drugs on all-cause, in-hospital mortality, the degree of respiratory failure and inflammation, and viral clearance in the oropharynx.
The 'NOR-Solidarity' study, an independent, add-on, randomised controlled trial to the World Health Organization (WHO) Solidarity trial, found that neither remdesivir nor HCQ affected viral clearance in hospitalised patients with COVID-19.
The WHO Solidarity trial had shown no effect of remdesivir or HCQ on mortality but did not assess antiviral effects of these drugs.
The latest study found no significant differences between treatment groups on mortality during hospitalisation.
The researchers also found that remdesivir and HCQ did not affect the degree of respiratory failure or inflammation.
There was a significant decrease in SARS-CoV-2 load in the oropharynx during the first week in all treatment groups, with similar decreases in 10-day viral loads.
The lack of antiviral effect with remdesivir and HCQ remained consistent despite patient age, symptom duration, degree of viral load, and presence of antibodies against SARS-CoV-2.
The researchers noted that overall mortality in NOR-Solidarity was lower than in the WHO-Solidarity trial.
This could be due to early lockdown policies in Norway during the initial phase of the pandemic, reducing pressure on hospitals and health care systems, the researchers said.
Norway also had lower rates of comorbid conditions such as diabetes and chronic heart disease, they said.
Based on their findings, the researchers question the antiviral potential of remdesivir and HCQ.
The treatment protocol recommended by the National Task Force has been approved by the Drug Controller General of India (DGCI) for restricted use in emergency situations.
Commenting on the lockdown initiated by several states to contain the coronavirus infection, a health ministry official said the states have been told to order superintendents of police and district magistrates to enforce the lockdown strictly.
"Partial lockdown defeats the purpose of breaking the chain of transmission of novel coronavirus," the official said.
On private laboratories being allowed to conduct testing for COVID-19, Bhargava said 12 private-lab chains have been registered and have started working after being allowed the testing.
These 12 labs have 15,000 collection centres, he said.
So far the country has reported 415 cases, the health ministry officials said, adding the death toll stands at seven.
Read: COVID-19 Breaking: France Claims 100 Percent Cure For Coronavirus
The anti-malarial drug (Hydroxychloroquine), has now become the most sought after medicine after reports emerged that it is proving effective in the fight against coronavirus.
It is being claimed that Hydroxychloroquine has disappeared from the drug stores in Indore and some even claim that the drug is being supplied to the United States.
As per the initial study, chloroquine treatment of COVID-19 patients had clinical and virologic benefit versus a comparison group. Chloroquine was added as a recommended antiviral for COVID-19 treatment, though clinical trials are still going on.
Sources said that pharmaceutical company Ipca Laboratories share price surged over 12 percent on Monday after the United States Food and Drug Administration (US FDA) partially lifted the import ban on chloroquine supply. Ipca Laboratories manufactures chloroquine. It has also informed the BSE and the NSE about the demand for the drug in the US.
It has said in the filing to the exchanges that due to the shortage implications or medical necessity of certain drugs and finished products, the FDA has made an exception to the import of the company's Active Pharmaceutical Ingredients (APIs) and finished products including Hydroxychloroquine Sulphate and Chloroquine Phosphate produced at the Company's manufacturing units. The demand for drugs for COVID-19 treatment is escalating high.
The president of Indore Drug Association told IANS, "it is true that this drug is not available over the counter in Indore."
However, Ipca lab refused to answer queries on the US demand for the drug saying it is a corporate matter.
(With Agency Inputs)
Also Read: COVID-19 Positive Cases In India Rise To 415, Govt Warns Of Legal Action Against Lockdown Violators
Speaking to the media at a press conference, Raman Gangakhedkar (scientist) said, "Do not go for COVID-19 test just on suspicion or consume hydroxychloroquine medicine without a doctor's prescription because the medicine has its side effects. Observe social distancing even at home with your family members."
Gangakhedkar also said that although the ICMR approved to give hydroxychloroquine in some cases, but it was still at an experimental level.
"The empiric use of hydroxychloroquine for prophylaxis of SARS-Cov-2 infection is recommended only for asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory-confirmed cases," he said.
Read: COVID-19 Treatment: ICMR Recommends Hydroxychloroquine For Patient Carers, Healthcare Workers
Gangakhedkar added that the ICMR would not recommend medicine for children below 15 years and elderly people above 60 years of age as it had many side effects on kidney and heart.
"There is sufficient access to testing so there is no need to panic. It is not just the government's responsibility to keep you healthy but you will have to be responsible for your own health. Therefore, follow all the instructions of social distancing given by the government," said the doctor.
There are now 118 government laboratories included in the ICMR network for COVID19 testing. The network has the capacity to test 12,000 samples a day.
"On an average, we have been testing at least 1,350 samples per day," Gangakhedkar informed the media.
Besides this, 22 private laboratory chains with about 15,500 collection centres have been registered with the ICMR till today for conducting tests for novel coronavirus, Gangakhedkar said.
According to the mathematical model of transmission of COVID-19, if social distancing is followed sincerely, the threat of coronavirus transmission could be reduced by 62 to 90 per cent in a week, Gangakhedkar said.
Lav Agarwal, Joint Secretary at the Ministry of Health and Family Welfare, was also present at the press conference. He said the ministry has asked states to make dedicated COVID-19 hospitals.
"As per the information we've received so far, work has started at the state level in Gujarat, Assam, Jharkhand, Rajasthan, Goa, Karnataka, Madhya Pradesh, and Jammu & Kashmir,"- Agarwal said.
Also Read: Coronavirus Outbreak: PM Modi Announces 21-Day Nationwide Lockdown From Tonight
According to a late-night notification by the Ministry of Commerce and Industry, the export of medication and the composition ingredients used for its manufacturing have been banned.
"The export of Hydroxychloroquine and formulations made from Hydroxychloroquine under any ITCHS Code... is prohibited with immediate effect," the DGFT under the ministry said in the notification.
Recently, the national task force for COVID-19 constituted by the Indian Council for Medical Research (ICMR) has recommended hydroxy-chloroquine as a preventive medication.
Also Read: ICMR Warns Against COVID-19 Tests On Suspicion, Hydroxychloroquine Sans Prescription
ICMR Director-General Balram Bhargava said that the compound is recommended only for a healthcare worker who is treating a Covid-19 patient.
"Secondly, it's recommended only for persons staying and caring for a household positive patient. They can take that only for prophylaxis, only for prevention," he added.
"Hydroxy-chloroquine is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from the available evidence of benefit as treatment and supported by preclinical data," the advisory said.
ICMR told the states that the placing of healthcare workers under chemoprophylaxis with hydroxy-chloroquine should not instil a sense of false security.
Meanwhile, Raman Gangakhedkar, senior scientist at the Indian Council for Medical Research (ICMR), on Tuesday warned against using a drug called hydroxychloroquine against coronavirus without medical prescription.
Speaking to the media at a press conference, Gangakhedkar said, "Do not go for COVID-19 test just on suspicion or consume hydroxychloroquine medicine without a doctor's prescription because the medicine has its side effects. Observe social distancing even at home with your family member's."
Gangakhedkar also said that although the ICMR approved to give hydroxychloroquine in some cases but it was still at an experimental level.
"The empiric use of hydroxychloroquine for prophylaxis of SARS-Cov-2 infection is recommended only for asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19 and asymptomatic household contacts of laboratory-confirmed cases," he said.
Gangakhedkar added that the ICMR would not recommend the medicine for children below 15 years and elderly people above 60 years of age as it had many side effects on kidney and heart.
Also Read: Coronavirus Outbreak: PM Modi Announces 21-Day Nationwide Lockdown
"There is sufficient access to testing so there is no need to panic. It is not just government's responsibility to keep you healthy but you will have to be responsible for your own health. Therefore, follow all the instructions of social distancing given by the government," said the doctor.
Recently, the FDA also freed India's IPCA from import ban so that it can ship unproven COVID-19 treatments. The FDA in 2015 banned products from three IPCA manufacturing facilities.
(IANS)
The Ministry of Health and Family Welfare on Thursday made the announcement making it clear that the order "shall come into force on the date of its publication in the official Gazette".
In the order, the government declared that the Central government is "satisfied that the drug hydroxychloroquine is essential to meet the requirements of emergency arising due to pandemic COVID-19 and in the public interest, it is necessary and expedient to regulate and restrict the sale and distribution of the drug 'hydroxychloroquine' and preparation based thereon for preventing their misuse".
Also Read: COVID-19 Outbreak: Govt Bans Export Of Hydroxychloroquine
"Now, therefore, in exercise of the powers conferred by Section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central govemment hereby directs that sale by retail of any preparation containing the drug Hydroxychloroquine shall be in accordance with the conditions for sale of drugs specified in Schedule H1 to the Drugs and Cosmetics Rules, 1945."
The order came at a time when the novel coronavirus claimed 16 lives and infected over 600 people across India.
The announcement regarding ban of sale and distribution of the drug was made by the government earlier but it issued an official Gazette notification on Thursday signalling that hydroxychloroquine -- an anti-Malaria drug -- will work as a medicine for treating coronavirus infected patients as well.
Recently, the national task force for COVID-19 constituted by Indian Council for Medical Research (ICMR) has recommended hydroxy-chloroquine as a preventive medication.
“The export of Hydroxychloroquine and formulations made from Hydroxychloroquine under any ITCHS Code… is prohibited with immediate effect,” the DGFT under the ministry said in the notification.
Also Read: ICMR Warns Against COVID-19 Tests On Suspicion, Hydroxychloroquine Sans Prescription
ICMR Director-General Balram Bhargava said that the compound is recommended only for a healthcare worker who is treating a Covid-19 patient.
“Secondly, it’s recommended only for persons staying and caring for a household positive patient. They can take that only for prophylaxis, only for prevention,” he added.
“Hydroxy-chloroquine is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from the available evidence of benefit as treatment and supported by preclinical data,” the advisory said.
(IANS)
Trump said that he spoke to Prime Minister Modi on Saturday morning and made a request to release Hydroxycholoroquine for the US.
"I called Prime Minister Modi of India this morning. They make large amounts of Hydroxychloroquine. India is giving it a serious consideration," Trump said at his daily news conference at the White House on Saturday.
Also Read: University Of Pittsburgh Reports Successful COVID-19 Vaccine Trial
India's Directorate General of Foreign Trade on March 25 banned the export of Hydroxychloroquine but said that certain shipments on humanitarian grounds may be allowed on a case-by-case basis.
With more than three lakh confirmed cases of coronavirus infection and over 8,000 fatalities, the US has emerged as the worst sufferers of the deadly coronavirus diseases to which there has been no cure.
Scientists across the world in particular in the US are racing against time to find either a vaccine or a therapeutic cure to the virus that has so far killed more than 64,000 people and infected 1.2 million in more than 150 countries.
Based on some initial results, the Trump administration is banking heavily on using Hydroxychloroquine, a decades old malaria drug, for the successful treatment of coronavirus.
Following a quick provisional approval from the US Food and Drug Administration last Saturday, the malaria drug along with a combination of some other drug is being used in the treatment of about 1,500 COVID-19 patients in New York.
According to Trump, the drug is yielding positive results. If successful, he told reporters that it would be a gift from heaven.
In the next several weeks, health experts in the US has projected between 100,000 to 200,000 deaths due to coronavirus, which due to human-to-human transmission is spreading like a wildfire in the US.
In anticipation of it being a successful drug in the treatment of coronavirus, the US has already stockpiled some 29 million doses.
It is in this context Trump requested Modi to help US get millions of doses of Hydroxychloroquine, a malaria drug that can be produced at mass scale in India.
Trump said he would appreciate if India releases the amount of Hydroxychloroquine that the US has ordered.
"And I said I would appreciate if they (India) would release the amounts that we ordered, he said, without mentioning that quantity of Hydroxychloroquine that has been ordered by US companies from India.
The Trump administration has made Hydroxychloroquine as part of its Strategic National Stockpile.
Trump said that people in malaria affected-countries take Hydroxychloroquine and not many people are infected by coronavirus.
Trump said that he would take Hydroxychloroquine, if needed.
Also Read: COVID-19 Testing, Treatment Free For Ayushman Bharat Beneficiaries: NHA
"I think people should if it were me, in fact, I might do it anyway. I may take it, Ok? I may take it. And, I'll have to ask my doctors about that, but I may take it, he said in response to a question.
(PTI)
Last week Trump said that he has sought help from Prime Minister Narendra Modi to allow the sale of Hydroxychloroquine tablets ordered by the US to treat the growing number of coronavirus patients in his country, hours after India banned the export of the anti-malarial drug.
I would be surprised if he would, you know, because India does very well with the United States, Trump told reporters during a press briefing at the White House on Monday.
Also Read: Covid-19: Trump Admin Recommends Face Masks As US Death Toll Crosses 7,100
Hydroxychloroquine tablet is used to prevent and treat malaria, lupus and rheumatoid arthritis, among other ailments.
The drug is seen as to offer a viable therapeutic solution to coronavirus that has so far taken the lives of more than 10,000 Americans and infected over 3.6 lakhs, just in a matter of weeks.
Last month, India imposed a ban on export on Hydroxychloroquine, on which Trump is now banking heavily in the treatment of COVID-19 patients.
India has received similar requests from several other countries including its immediate neighbours like Sri Lanka and Nepal. India has said that it is reviewing its export ban order.
Notably, India's decision to ban the exports of Hydroxychloroquine is driven by its desire to take stock of the domestic requirements and ensure that the country has enough in its kitty.
Reiterating that for many years, India has been taking advantage of the US on trade, Trump said that he would be surprised if New Delhi was to stop export of Hydroxychloroquine to the US.
So, I would be surprised if that were his decision. He'd have to tell me that. I spoke to him Sunday morning, called him, and I said we'd appreciate your allowing our supply to come out. If he doesn't allow it to come out, that would be okay, but of course there may be retaliation. Why wouldn't there be? Trump said.
I spoke to him (PM Modi) & I said we appreciate it that you are allowing our supply (of Hydroxychloroquine) to come out, if he doesn't allow it to come out, that would be okay, but of course, there may be retaliation, why wouldn't there be?: US Pres Donald Trump (ANI) #COVID19 pic.twitter.com/2CkG4wgn2K
— OTV (@otvnews) April 7, 2020
On Monday, a senior State Department official said that India has been a significant partner of the US in the pharmaceutical sector and it expects similar cooperation to continue between the economies.
India has long been a significant partner of the United States and the pharmaceutical sector, Alice G Wells, the Acting Assistant Secretary of State for South and Central Asia, told reporters during a press briefing.
The Trump administration has already created a national strategic stockpile of 29 million doses of the malaria drug, anticipating that its test results on more than 1,500 COVID-19 patients in New York is yielding positive results.
Scientists have begun testing Hydroxychloroquine and chloroquine as candidates for potential COVID-19 treatments and the FDA last week issued an Emergency Use Authorization for the prescription of the drugs in certain circumstances.
Also Read: UK PM Boris Johnson Taken Into Intensive Care With Coronavirus
In addition to New York, COVID-19 patients in several States are being treated with Hydroxychloroquine, including Michigan and Texas.
(PTI)
It seems we have little choice but to brace for a fresh spell of ‘lockdown’ – a state we Indians, with the exception of the people of Jammu & Kashmir, had no previous experience of till a month ago, but now know like the back of our palm. The modern day ‘Battle of Mahabharat’ that Prime Minister Narendra Modi had ordained to last 21 days while announcing the nationwide lockdown from March 24 on TV now looks all set to last beyond April 14, the date scheduled by the PM for the ‘epic war’ to come to an end. With the ‘enemy’ turning out to be a much tougher nut to crack than anyone, including the PM, had imagined, it is obvious that there is no way the war is going to be won in the stipulated period.
The ‘enemy’, a tiny virus called nCorona, has displayed such amazing staying powers, fighting skills and firepower that even the ‘most powerful’ nation in the world has been brought down to its knees! Amazingly though, while the virus has inflicted the maximum damage to the most advanced countries like the US, Italy, Britain and France, the impact has been much less in ‘poor’ countries like India and Pakistan. Nothing illustrates the changing world order better than US literally begging India for ammunition in the shape of hydroxychloroquine tablets to fight the War on Corona! t seems it is a divinely ordained design to redraw the power equations in the world.
Also Read: ‘Lockdown’ Isn’t Such A Terrible Thing After All!
But the big question in India right now is not the changing world order, but whether an extension of the lockdown period is practicable and sustainable? My own view, for whatever little it is worth, is that it isn’t. Let us not forget that the number of cases in the country, which stood at around 500 when the lockdown started, has grown 10-fold to more than 5, 000 (with more than 150 dead) in just the first two weeks of the three-week period despite all the unprecedented restrictions in place. The rate at which the numbers are growing, there is little doubt that it would have gone up by a few thousands more by the scheduled end of the lockdown on April 14. So, it is not as if the lockdown has arrested the spread of the deadly virus.
Of course, a big reason for the rising numbers is the fact that people have refused to abide by the restrictions imposed by the government as part of the lockdown and take the precautionary measures essential to keep the virus at bay. Despite using all the powers of persuasion and force at their command, both the central and state governments have found it well-nigh impossible to enforce the lockdown in letter and spirit. If it could not be enforced during the first 21 days, where is the guarantee that it can be achieved after the extension? If anything, adherence is likely to become even more lax if it continues beyond April 14. If the government decides on tightening the screws further in a bid to enforce the restrictions, I have a feeling it might backfire and create a new and much bigger problem for the government to contend with. Already exasperated with the loss of earnings for three weeks, India’s poor could run out of patience, abandon the fear of the police danda and start defying the orders in large numbers. This could lead to a law and order problem of unprecedented proportions for the governments - and that too without achieving the purpose for which the screws were tightened in the first place!
It is all very well for the well-heeled people, sitting in the comfort of their air conditioned, well-stocked homes, to watch the ‘wretched of the earth’ venture out of their homes on TV and exclaim; “Why can’t these god-forsaken people just stay indoors?” But for the man who does not know where his next meal will come, death by Corona is any day preferable to death due to starvation. And they are the people who not only constitute the majority, but have been hit the hardest by the complete ‘lockdown’ of all economic activity forced on the country. A nationwide extension of the lockdown will prove disastrous for this vast population, besides causing more and lasting damage to the nation’s economy, already down in the dumps. Of course, there are willful defaulters who venture out not to earn a living, but for fun. But you cannot punish the overwhelming majority of people who are compelled to come out of their homes for economic reasons and not to have ‘fun’.
Also Read: Fault-Finding Can Wait For A More Opportune Time
It is a real Hobson’s choice for the Union government. Lift the lockdown on April 15 as scheduled and risk witnessing a huge spurt in positive cases; extend it and risk creating a massive, countrywide law and order problem. In the event, the best course would perhaps be not to declare a nationwide extension of the lockdown but to let state governments deal with the situation as they see fit. By now, all state governments know what needs to be done to check the spread of the virus. Let them take a call after taking their own situation into consideration. The best course, as of now, appears to be continuation of the lockdown - and even a further tightening of the restrictions in areas identified as ‘hotpots’ – while lifting the curbs in other areas in a phased manner.
A uniform, nationwide extension of the lockdown, in contrast, could prove disastrous; for the country, its economy and, most importantly, its vast army of working class people.
(DISCLAIMER: This is an opinion piece. The views expressed are the author’s own and have nothing to do with OTV’s charter or views. OTV does not assume any responsibility or liability for the same)
In his morning tweet, Donald Trump said, "Extraordinary times require even closer cooperation between friends. Thank you, India and the Indian people for the decision on HCQ. Will not be forgotten! Thank you, Prime Minister Narendra Modi, for your strong leadership in helping not just India, but humanity, in this fight!"
Extraordinary times require even closer cooperation between friends. Thank you India and the Indian people for the decision on HCQ. Will not be forgotten! Thank you Prime Minister @NarendraModi for your strong leadership in helping not just India, but humanity, in this fight!
— Donald J. Trump (@realDonaldTrump) April 8, 2020
President Trump's admiration for Modi and gratitude towards India put rest to several speculative media reports that claimed that the Indian government had taken the decision to lift the ban on the export of HCQ under the "threat of retaliation" in international trade by the US.
Prime Narendra Modi also responded to President Trump's tweet and said, "Times like these bring friends closer. The India-US partnership is stronger than ever."
Fully agree with you President @realDonaldTrump. Times like these bring friends closer. The India-US partnership is stronger than ever.
India shall do everything possible to help humanity's fight against COVID-19.
We shall win this together. https://t.co/0U2xsZNexE
— Narendra Modi (@narendramodi) April 9, 2020
Also Read: Would Be Surprised If India Doesn’t Allow Export Of Hydroxychloroquine To US: Donald Trump
At a White House press briefing on Monday President Trump, in response to a question whether he was worried about "retaliation to the US ban on export of medical goods" from India, had said, "I would be surprised if he (Modi) would, you know, because India does very well with the US... I spoke to him Sunday morning, called him, and I said, we'd appreciate you allowing our supply (of HCQ) to come out. If he doesn't allow it to come out, that would be ok. But of course, there may be retaliation. Why wouldn't there be?"
Trump's response to the reporter's leading question was construed by some sections of Indian media as a threat even as the government denied that it had taken the decision under any pressure.
In view of the humanitarian aspects of the pandemic, India on Tuesday decided to licence paracetamol and HCQ in appropriate quantities to neighbouring countries who are dependent on Indian capabilities. India will also be supplying these essential drugs to some nations which have been particularly badly affected by the pandemic, a ministry of external affairs statement said.
The US as of now has the highest number of COVID-19 pandemic cases in the world, with over 418,000 cases of infections and over 14,200 deaths. Relatively, India has managed to contain the pandemic with 178 deaths and over 5900 cases of infections.
The Directorate General of Foreign Trade has notified lifting restrictions on 14 drugs. Paracetamol and HCQ, have been kept in a licensed category and their demand status is to be continuously monitored. HCQ is being used to treat COVID-19 patients and as prophylactic by the frontline health care workers deployed in the fight against the coronavirus pandemic. The Modi government had imposed a ban on export of the drug since the coronavirus outbreak hit India.
Also Read: Donald Trump Warns To Put A Hold On WHO Funding
(IANS)
The first participants have enrolled in the trial at Vanderbilt University Medical Center, Tennessee, reported Xinhua news agency.
The blinded, placebo-controlled randomized clinical trial aims to enrol more than 500 adults who are currently hospitalized with COVID-19 or in an emergency department with anticipated hospitalization.
All participants in the study will continue to receive clinical care as indicated for their condition. Those randomized to the experimental intervention will also receive hydroxychloroquine, according to the NIH.
"Effective therapies for COVID-19 are urgently needed," said James Kiley, director of the Division of Lung Diseases of the National Heart, Lung, and Blood Institute, part of the NIH.
"Hydroxychloroquine has shown promise in a lab setting against SARS-CoV-2, the virus that causes COVID-19 and preliminary reports suggest potential efficacy in small studies with patients. However, we need clinical trial data to determine whether hydroxychloroquine is effective and safe in treating COVID-19," he said.
While COVID-19 usually presents as an acute respiratory infectious illness, it can damage multiple organ systems, including heart, lung, and blood.
Currently, no therapies have been demonstrated to prevent the progression of COVID-19 to severe illness, but several medicines available in the United States have been proposed as potential therapies, said the NIH.
Also Read: COVID-19 Could Push Half A Billion People Into Poverty: UN
Hydroxychloroquine is used to treat malaria and rheumatoid conditions such as arthritis. In various studies, the drug has demonstrated antiviral activity, an ability to modify the activity of the immune system, said the NIH.
The drug has an established safety profile at appropriate doses, leading to the hypothesis that it may also be useful in the treatment of COVID-19, according to the NIH.
In the US, 11 out of 100 people under the age of 25, 17 per cent of those in the 25 to 45 age group and 21 per cent of those between 45 and 65 years who presented with symptoms have tested positive for coronavirus, according to age-wise testing data available for the first time from the White House on a day when America's death toll climbed past the 16,500 marks with total confirmed cases more than 462,000.
On the same day, New York State suffered the deadliest blow, posting a record-breaking increase in coronavirus deaths for a third consecutive day even as hospitalisations and intubations slowed, suggesting the curve is finally flattening. The net 200-patient increase in hospitalisations is the lowest since the nightmare began.
Also Read: COVID-19 Cases To Reach 1 Million In Next Few Days, Toll To Hit 50,000- WHO
White House data is also showing that US men are testing positive at a much higher rate than women.
Data on those under 25 years were drawn from a universe of 200,000 tests while more than half a million people in the 25-45 years age group and the 45-65 age group have been tested, according to Dr Deborah Birx, who is coordinating the White House response to the pandemic.
Among 200,000 people in the 65-85 age group, Birx reported 22 per cent positive tests and a slightly higher 24 per cent positivity level among 30,000 people above 85 years who were tested.
The pattern emerging from the US testing data are consistent with insights the White House has absorbed from attack rates in other countries which have come off their infection peaks, especially Europe.
Birx urged American men who are symptomatic to get tested. So far, nearly 6 in 10 people who have been tested are female while a little more than 4 in 10 are men. Positivity rates are 16 per cent for women and 23 per cent for men.
"Men often don't present in the healthcare delivery system until they have greater symptomatology. This is to all of our men out there no matter what age group. If you have symptoms, you should be tested, and make sure that you are tested," Birx said.
More than 6 in 10 states, Birx said, have less than 10 per cent positive rate "despite significant testing".
"Issues around those with comorbidities and those of the elderly" continue to be the dominant concerns, according to Birx.
Despite the rising tide of horrible news, the White House task force remains focused on the upside of mitigation efforts which are showing up as flatter curves in outbreaks outside the New York and New Jersey metro areas.
Birx said the curves in Washington, Philadelphia, Baltimore and Denver "are much lower than New York and New Jersey and this gives us hope".
America's top infectious diseases expert on the White House task force Dr Anthony Fauci backed up Birx's comments saying America is headed in the "right direction".
"That means that what we are doing is working, and therefore we need to continue to do it. I know I sound like a broken record, that's good - I want to sound like a broken record, let's just keep doing it," Fauci said about continued adherence to social distancing guidelines in place since March 16.
Predictive models from the Institute For Health Metrics and Evaluation at the University of Washington which earlier projected a nationwide death toll of 100,000-200,000 have now revised downwards to a little over 60,000 deaths by August first week of this year. These models assume "full social distancing" in place.
Fauci announced, "broad, general good news" on the race for therapeutics that can serve as a stop-gap measure until a vaccine is ready.
"There is a lot of candidate potential therapeutics that are going into clinical trials now that we're sponsoring at the NIH," Fauci said.
NIH is short for National Institutes of Health, a part of the U.S. Department of Health and Human Services, and the country's foremost medical research agency.
Also Read: Boris Johnson Moves Out Of ICU, ‘In Extremely Good Spirits’: Govt
These trials, Fauci said, would give scientists the answers they seek on safety, effectiveness and the circumstances under which the drugs can be used as prophylaxis in early and late-stage disease.
"We're doing an awful lot from a scientific standpoint, so that when we do get to next year, next Fall, next winter, hopefully, we'll have something that we can offer."
A vaccine, Fauci has maintained since the US outbreak began, will take anywhere from "12-18 months".
(IANS)
India is the biggest manufacturer of the anti-malarial drug that is being touted as 'game changer' in the fight against the COVID-19 pandemic.
Also Read: Govt Removes Customs Duty, Health Cess On Ventilators, COVID-19 Test Kits
"There is enough stock of hydroxychloroquine in the country and we are tracking its demand, availability and production on a daily basis," National Pharmaceutical Pricing Authority (NPPA) Chairman Shubhra Singh told PTI.
India is the world's largest manufacturer of the drug, which is used for treatment of rheumatoid arthritis, malaria and lupus, she added.
"Ensuring the availability of the drug in the country is our first priority. Only after meeting the demand here, the exports are being done," Singh said.
She, however, cautioned that the medicine should only be taken on the advice of doctors.
India manufactures 70 per cent of the world's supply of hydroxychloroquine. Companies like IPCA and Zydus Cadila are the major manufacturers of hydroxychloroquine in the country.
The Indian pharmaceutical industry earlier this week said there is enough stock of hydroxychloroquine in the country and drug firms are ready to ramp up the production to meet domestic as well as export requirements.
India currently has an annual installed capacity of around 40 tonnes of active pharmaceutical ingredients (APIs) of hydroxychloroquine. With this capacity, it can make around 200 million tablets of 200 mg, which can be ramped up, the Indian Drug Manufacturers' Association (IDMA) had said.
Also Read: Fighting COVID-19: ADB Assures USD 2.2 Bn Support Package To India
The production capacity in the country is sufficient to meet the current demand. If the need arises, the companies are committed to ramp up production, the Indian Pharmaceutical Alliance had earlier told PTI.
India on Tuesday had decided to partially lift the ban on the export of anti-malarial drug hydroxychloroquine in sync with its global commitment to deal with the coronavirus pandemic.
(PTI)
According to the ministry's "Updated containment plan for large outbreaks COVID-19", a containment operation (large outbreak or cluster) is deemed to be over 28 days from the date the last case in that zone tests negative.
The closing of the surveillance for the clusters could be independent of one another provided there is no geographic continuity between clusters. However, the surveillance will continue for severe acute respiratory infection (SARI) and influenza-like illness (ILI).
States shall ensure that all required steps are taken to contain clusters within the large outbreak and chain of transmission is broken, it said.
The document stated that in India also, clusters and large outbreaks have been noted in parts of the country and unless they are contained in time, the risk of further spread remains very high.
Also Read: COVID19 Cases’ Doubling Reduced After Lockdown, Growth Factor Down By 40%: Govt
Large number of cases has been reported from Maharashtra, Delhi, Tamil Nadu, Madhya Pradesh and Rajasthan.
The Centre has declared 170 hotspots -- 123 hotspot districts with large outbreaks and 47 hotspot districts with clusters. Besides, it has identified 207 non-hotspot districts with clusters.
The ministry in its updated containment plan for large outbreaks, said India is preparing for a 'scenario based approach' in tackling the disease.
According to the Health Ministry's document, "containment for large outbreaks through geographic quarantine strategy calls for near absolute interruption of movement of people to and from a relatively large defined area where there is single large outbreak or multiple foci of local transmission" of COVID-19.
In simple terms, it is a barrier erected around the focus of infection. Geographic quarantine shall be applicable to such areas reporting large outbreak or multiple clusters of COVID-19 spread over multiple blocks of one or more districts that are contiguous based on the distribution of cases and contacts.
It said the strategy, at present, is aimed at containment of large outbreaks, through perimeter control, active searches of cases, isolation, testing suspect cases and patients of severe acute respiratory infection (SARI) among others.
It also include implementation of social distancing measures with strict perimeter control, providing chemoprophylaxis with hydroxychloroquine to all asymptomatic healthcare workers and asymptomatic household contacts of laboratory confirmed cases.
The document stated that each such area from where the cases are being reported would have a containment zone, and a buffer zone will be created in its neighbouring areas.
Passive surveillance would be enhanced all throughout the area under geographic quarantine and the buffer zone.
The document said after the precise mapping of the outbreak, in the containment zone a designated health worker will visit on an average 50 households.
The surveillance workers will interview members of the household through a questionnaire on signs, symptoms, travel history, history of contact with a confirmed or suspected COVID-19 case.
The perimeter control will ensure that there is no unchecked outward movement of population from the containment zone except for maintaining essential services (including medical emergencies) and government business continuity, the document said.
All roads, including rural roads, connecting the containment zone will be guarded by police and for personnel and vehicles requiring regular movement, a pass or ID card may be issued with details recorded, it said.
According to the document details of all persons moving out of perimeter zone for essential/ emergency services will be recorded and they will be followed up through IDSP.
Also Read: COVID-19 Tests: ICMR notifies 176 govt and 78 private labs
Also vehicles moving out of the perimeter control will be decontaminated with sodium hypochlorite (1 per cent) solution.
(PTI)
Asked by a reporter at his daily briefing on Thursday about India sending aid to several countries facing the COVID-19 pandemic, Dujarric said: "The secretary-general calls for global solidarity in this struggle against the virus. That means that every country who is in a position to help another country should. We salute those countries that are doing so."
India has offered to help member countries of the South Asia Association for Regional Cooperation (SAARC) and has sent medicines to several countries, including the US, Brazil and Israel.
India has sent its military health professionals to Kuwait and Maldives to help deal with the pandemic.
In contrast to the UN reaction, within India the sending of hydroxychloroquine to the US has been criticised by Congress Party leader Rahul Gandhi and others from his organisation.
The government on April 10 had said that there is enough stock of hydroxychloroquine in the country and it is taking all steps to ensure that there is no shortage of the drug in the domestic market.
India is the biggest manufacturer of the anti-malarial drug that is being touted as ‘game changer’ in the fight against the COVID-19 pandemic.
“There is enough stock of hydroxychloroquine in the country and we are tracking its demand, availability and production on a daily basis,” National Pharmaceutical Pricing Authority (NPPA) Chairman Shubhra Singh told PTI.
Also Read: Fighting COVID-19: ADB Assures USD 2.2 Bn Support Package To India
India is the world’s largest manufacturer of the drug, which is used for treatment of rheumatoid arthritis, malaria and lupus, she added.
“Ensuring the availability of the drug in the country is our first priority. Only after meeting the demand here, the exports are being done,” Singh said.
She, however, cautioned that the medicine should only be taken on the advice of doctors.
India manufactures 70 per cent of the world’s supply of hydroxychloroquine. Companies like IPCA and Zydus Cadila are the major manufacturers of hydroxychloroquine in the country.
The Indian pharmaceutical industry earlier this week said there is enough stock of hydroxychloroquine in the country and drug firms are ready to ramp up the production to meet domestic as well as export requirements.
India currently has an annual installed capacity of around 40 tonnes of active pharmaceutical ingredients (APIs) of hydroxychloroquine. With this capacity, it can make around 200 million tablets of 200 mg, which can be ramped up, the Indian Drug Manufacturers’ Association (IDMA) had said.
Also Read: Govt Removes Customs Duty, Health Cess On Ventilators, COVID-19 Test Kits
The production capacity in the country is sufficient to meet the current demand. If the need arises, the companies are committed to ramp up production, the Indian Pharmaceutical Alliance had earlier told PTI.
India on Tuesday had decided to partially lift the ban on the export of anti-malarial drug hydroxychloroquine in sync with its global commitment to deal with the coronavirus pandemic.
(With Agency Inputs)
The Drug Controller General of India said ICMR has submitted a list of institutes, which have shown an interest in the trial, to the Central Drugs Standard Control Organisation and they may do so in consultation with the health research body.
"It is to inform that in light of public interest the proposal of ICMR for conducting the said trial has been reviewed through the Subject Expert Committee in its meeting held on April 13 under accelerated approval process in light of the current prevailing situation of COVID-19 and based on the recommendation of the committee.
Also Read: COVID-19 Fight: China Develops Nanomaterial, US Develops Therapies To Combat Coronavirus
"The CDSCO has conveyed its no objection for conduct of the clinical trial subject to certain amendments in the protocol and various conditions under the Drugs and Clinical Trial Rules 2019," the central drug regulator said in a notice.
The notice underlined that ICMR has developed a protocol for a controlled clinical trial with convalescent plasma in moderate COVID-19 patients which has been reviewed by the committee and the same may also be considered by the applicants as appropriate.
In convalescent plasma therapy, antibodies from the blood of patients who have recovered from COVID-19 are used to treat severely infected patients.
The study is aimed at assessing the efficacy of convalescent plasma to limit complications in COVID-19 patients and to evaluate the safety of treatment with anti SARS-CoV-2 plasma in coronavirus-infected patients.
The death toll due to COVID-19 rose to 480 and the number of cases in the country climbed to 14,378 on Saturday, according to the Union Health Ministry.
The ICMR has already sought participation in a phase-II randomised controlled trial to assess the safety and efficacy of convalescent plasma.
Currently, there are no approved treatments for COVID-19. The management plan is supportive care with supplemental oxygen and mechanical ventilation.
Multiple trials are being done across the globe to assess the efficacy of various treatment strategies, the ICMR said.
The WHO initiated the "solidarity trial" in several countries to compare the effectiveness of the following regimens against COVID-19: Remdesivir, Lopinavir/Ritonavir, Lopinavir/Ritonavir with interferon beta, and Hydroxychloroquine.
In a clinical trial, Lopinavir/Ritonavir did not demonstrate any benefit over standard of care.
The US FDA recently approved convalescent plasma from patients recovered from COVID-19 for the treatment of severe or life-threatening COVID-19 infections.
In a small case series, five critically ill novel coronavirus-infected patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation.
In another small case series of four patients, including one pregnant woman, it was seen that all four recovered eventually, the ICMR said.
In another feasibility study of convalescent plasma therapy, 10 severely-ill patients were transfused with 200 ml of convalescent plasma and clinical symptoms rapidly improved in three days.
Also Read: India Received 5 Lakh Rapid COVID-19 Testing Kits From China: Health Ministry
Historically, it has been used in viral diseases such as poliomyelitis, measles, mumps and influenza before vaccines became available, the research body said.
A meta-analysis of 1,703 patients with H1N1 influenza during the Spanish Flu of 1918 suggested that patients who received convalescent plasma had lower mortality. Furthermore, 84 patients with Ebola virus disease who were transfused with convalescent plasma without known levels of neutralizing antibodies did not have a survival benefit.
Convalescent plasma was also studied during the previous coronavirus outbreak of SARS in 2002-2004. In a retrospective study of 80 patients, it was observed that patients who received convalescent plasma before day 14 of illness had better outcomes, defined as early hospital discharge, compared to patients who received it after day 14 of illness.
"Considering the lack of efficacious treatments for COVID 19 and the epidemic situation with high mortality rate, the US FDA has approved convalescent plasma for COVID-19 for clinical trials, expanded access and single patient emergency investigational new drugs," the ICMR said.
A majority of the adverse effects associated with plasma transfusion are non-lethal.
"We hypothesize that the use of convalescent plasma will improve the clinical outcomes in patients with moderate COVID-19 infection. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the convalescent plasma to limit complications in COVID-19 patients," the ICMR said.
(With PTI Inputs)
The FDA said it is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines.
"We are also aware of the increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind healthcare professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine," the agency said in a statement.
Also Read: Govt Restricts Sale Of ‘Hydroxychloroquine’ Amid Coronavirus Outbreak
Hydroxychloroquine, an anti-malarial drug termed potential "game-changer" for COVID-19 by US President Donald Trump, has disappeared from medical stores globally, including in India, putting millions at risk of self-medicating themselves with the drug.
The FDA said that it will continue to investigate the risks associated with the use of hydroxychloroquine and chloroquine for COVID-19.
"Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing Covid-19. They are being studied in clinical trials for COVID-19, and we authorised their temporary use during the Covid-19 pandemic for treatment of the virus in hospitalised patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorisation (EUA)," elaborated the FDA.
Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia.
Hydroxychloroquine, alone or in combination with azithromycin, is being used in COVID-19 therapy based on anecdotal and limited observational evidence in several countries.
Despite limited and conflicting data on the use of hydroxychloroquine in patients with Covid-19, the US FDA has authorised the emergency use of this drug when clinical trials are unavailable or infeasible.
"The risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition," cautioned the agency.
"Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines," it added.
Patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or autoimmune conditions should continue taking their medicine as prescribed.
"The benefits of these medicines outweigh the risks at the recommended doses for these conditions. Do not stop taking your medicine without first talking to your healthcare professional," warned the FDA statement.
Be aware that there are no proven treatments for COVID-19 and no vaccine, it said.
"Do not buy these medicines from online pharmacies without a prescription from your healthcare professional. Consumers should not take any form of chloroquine that has not been prescribed for them by a healthcare professional," the FDA noted.
Serious poisoning and death have been reported after mistaken use of a chloroquine product not intended to be taken by humans.
(IANS)
Read: ICMR Warns Against COVID-19 Tests On Suspicion, Hydroxychloroquine Sans Prescription
After the two of them tested positive, "I thought, you know, from my standpoint, not a bad time to take it, because we had the combination of those -- the two people," he said on Tuesday.
Trump has been criticised by Democratic Party leaders and some doctors for taking HCQ, which has been described in the media as a dangerous drug.
Chuck Schumer, the Democratic Party leader in the Senate, said Trump taking HCQ was "dangerous" and accused him of giving false hopes.
Trump said, "I've had no impact from it. I've now - I've had no - I feel the same. I haven't changed, I don't think, too much."
"But it seems to be an extra line of defence, and it's gotten tremendous reviews from some people, including many, many doctors all over the world," he added.
The Indian Council of Medical Research (ICMR) National Task Force on COVID-19 has recommended that healthcare workers and others caring for coronavirus patients use HCQ as a preventive.
While it has been used by millions around the world for decades to fight malaria and is commonplace, in the US the focus has been on the side effects of interference with heartbeats in some people.
Trump said, "It's gotten a bad reputation only because I'm promoting it. So I'm obviously a very bad promoter. If anybody else were promoting it, they'd say, 'This is the greatest thing ever'."
Veterans Affairs (VA) Secretary Robert Wilkie pointed out that HCQ is widely used in the military.
"Those of us who've had a military life -- some of us around this table -- we've been taking this drug for years," he said.
Both he and Trump disputed a study attributed in the media to the VA, the department that provides services for ex-servicepersons and runs a network of hospitals.
University of Virginia researcher Jayakrishna Ambati reported that the risk of death was found to be higher in ex-servicemen suffering from COVID-19 who were treated with it compared to those who were not.
Wilkes said, "That was not a VA study. Researchers took VA numbers and they did not clinically review them. They were not peer-reviewed."
Trump added, "That was a phony study, and it's very dangerous to do it."
Some studies in France and elsewhere have shown positive results for the use of HCQ and several studies are underway in the US, India and elsewhere.
Trump had personally requested Prime Minister Narendra Modi to relax the ban on HCQ export and allow India to export doses ordered before the COVID-19 pandemic.
India agreed and sent the US 3.5 million tablets and nine tonnes of ingredients to manufacture it.
(IANS)
As was mentioned in the earlier advisory, the drug against the infection is also recommended for all asymptomatic healthcare workers involved in containment and treatment of COVID-19 and household contacts of laboratory-confirmed cases.
The revised advisory issued by the ICMR, however, cautioned that the intake of the medicine should not instil a sense of false security.
The recommendation was made after the Joint Monitoring Group under the Chairmanship of Directorate General of Health Services (DGHS) and including representatives from AIIMS, ICMR, National Centre for Disease Control, National Disaster Management Authority, WHO and experts drawn from central government hospitals reviewed the prophylactic use of hydroxychloroquine (HCQ) in the context of expanding it to healthcare and other frontline workers deployed in non-COVID-19 and COVID-19 areas.
Three new categories ---all asymptomatic healthcare workers working in non-COVID hospitals/areas of COVID hospitals/blocks, asymptomatic frontline workers such as surveillance workers deployed in containment zones and paramilitary/police personnel involved in COVID-19 related activities ---have now been included.
According to the revised advisory, at NIV, Pune, the report of the in-vitro testing of HCQ for antiviral efficacy showed reduction of infectivity and log reduction in viral RNA copy of SARs-CoV2.
The drug is contraindicated in persons with known case of retinopathy, hypersensitivity to HCQ and cardiac rhythm disorders, it said.
The drug is not recommended for prophylaxis in children under 15 years of age and in pregnancy and lactation, the advisory said.
Rarely the drug causes cardiovascular side effects such as cardiomyopathy and rhythm (heart rate) disorders, it said.
"In that situation, the drug needs to be discontinued. The drug can rarely cause visual disturbance including blurring of vision which is usually self-limiting and improves on discontinuation of the drug," the revised advisory said.
The drug has to be given under strict medical supervision with informed consent, it stated.
The National Taskforce (NTF) for COVID-19 constituted by the ICMR reviewed the use of HCQ for prophylaxis of SARS-CoV-2 infection for high-risk population based on the emerging evidence on its safety and efficacy.
The data on the assessment of HCQ prophylaxis among 1,323 healthcare workers indicated mild adverse effects such as nausea (8.9 per cent), abdominal pain (7.3 per cent), vomiting (1.5 per cent), hypoglycemia (1.7 per cent) and cardiovascular effects (1.9 per cent), the advisory said.
However, as per the data from the Pharmacovigilance Programme of India, there have been 214 reported instances of adverse drug reactions associated with prophylactic HCQ use, it said.
Of these, seven were serious individual case safety reports with prolongation of QT interval on ECG in three cases, it added.
Highlighting the studies on prophylaxis of SARS-CoV-2 infection, the advisory stated that a retrospective case-control analysis at ICMR has found that there is a significant dose-response relationship between the number of prophylactic doses taken and frequency of occurrence of SARSCoV-2 infection in symptomatic healthcare workers who were tested for coronavirus infection.
Another investigation from three central government hospitals in New Delhi indicates that amongst healthcare workers involved in COVID-19 care, those on HCQ prophylaxis were less likely to develop SARS-CoV-2 infection, compared to those who were not on it.
The benefit was less pronounced in healthcare workers caring for a general patient population.
Besides, an observational prospective study of 334 healthcare workers at AIIMS, out of which 248 took HCQ prophylaxis in New Delhi also showed that those taking HCQ prophylaxis had lower incidence of SARS-CoV-2 infection than those not taking it.
According to the advisory, the drug has to be given only on the prescription of a registered medical practitioner and it is advised to consult with a physician for any adverse event or potential drug interaction before initiation of medication, it said.
Front line workers should use PPEs in accordance with the guidelines issued by the health ministry and they should be advised to consult their physician (within their hospital/surveillance team/security organisation) for any adverse event or potential drug interaction before initiation of medication, the advisory said.
If anyone becomes symptomatic while on prophylaxis, he/she should immediately contact the health facility, get tested as per national guidelines and follow the standard treatment protocol, it said.
Apart from the symptoms of COVID-19 (fever, cough, breathing difficulty), if the person on chemoprophylaxis develops any other symptoms, he should immediately seek medical treatment from the prescribing medical practitioner, it said.
All asymptomatic contacts of laboratory confirmed cases should remain in home quarantine as per the national guidelines, even if they are on prophylactic therapy, the advisory added.
(PTI)
You May Also Like:
Took HCQ after valet tested Covid-19 positive, says Donald Trump
COVID-19: FDA Warns Against Use Of Hydroxychloroquine Pills
The ICMR's statement came against the backdrop of the World Health Organization (WHO) suspending the testing of the drug in COVID-19 patients temporarily in its global study following safety concerns.
"The COVID-19 is an evolving field and we do not know which drug is working and which is not working. A lot of drugs are being repurposed for COVID-19, whether for prophylaxis or for treatment of COVID-19.
"We found there were no major side effects except for nausea, vomiting, palpitation occasionally. Hence in our advisory, we have recommended that it should be continued for prophylaxis as there is no harm. A benefit may be there," ICMR Director General Balram Bhargava said.
He said it has been "clearly advised that HCQ should be taken with food, not on empty stomach".
"We also emphasized that one ECG should be done during the treatment. We expanded use of HCQ from healthcare workers to front-line workers also, considering the potential benefits," he added.
Bhargava was addressing a press conference on the COVID-19 situation in the country where he mentioned that the ICMR has upscaled the testing facilities and over one lakh persons are being tested every day.
Lav Agarwal, Joint Secretary, Ministry of Health, said the recovery rate for COVID-19 cases in the country has seen an upwards trend.
The recovery rate in the country continues to improve and is presently 41.61 per cent. The COVID-19 fatality rate has reduced from 3.3 per cent on April 15 to 2.87 per cent which is among the lowest in the world," he said.
(PTI)
Related Stories:
COVID-19 Treatment: ICMR Issues Revised Advisory On Use Of Hydroxychloroquine
COVID-19 Treatment: ICMR Recommends Hydroxychloroquine For Patient Carers, Healthcare Workers
Just as context, this development comes at a time when hydroxychloroquine has proved ineffective in the first large study which tests it in people in close contact with COVID19 infected people. These results were published this week by the New England Journal of Medicine.
"Today, three of the authors of the paper, "Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis", have retracted their study. They were unable to complete an independent audit of the data underpinning their analysis. As a result, they have concluded that they "can no longer vouch for the veracity of the primary data sources", The Lancet said in a statement on Thursday.
Science Magazine quotes researchers and online investigators expressing shock that the retracted Lancet paper includes "astonishing number of patients and details about patient demographics and dosing that seemed implausible."
Soon after the study was published, large randomised trials of chloroquine and hydroxychloroquine came to a sudden halt.
Mehra, Ruschitzka, and Patel are three of the four authors who have retracted this study that has existed for exactly 13 days. The fourth author - Sapan Desai - is the founder of the company which supplied the database and is missing from the list of names in the Lancet retraction statement.
This study was first published on May 22 and concerns began mounting almost immediately about this and one more study in the New England Journal of Medicine where the same company - Surgisphere - supplied data.
The Surgisphere database in the retracted Lancet study has been in the spotlight because of its size a" nearly 100,000 patients".
On its website, Surgisphere defends its data integrity.
"Our studies, including that published in The Lancet, use a registry, with data obtained from electronic health records (EHR). In our hydroxychloroquine analysis, we studied a very specific group of hospitalised patients with COVID-19 and have clearly stated that the results of our analyses should not be over-interpreted to those that have yet to develop such disease or those that have not been hospitalised," says an excerpt from its statement.
The Lancet is not alone in retracting a COVID19 paper that has attracted widespread attention.
The New England Journal of Medicine today put out a thick paragraph retracting their article called "Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19." Here too, Surgisphere is the data pipeline, Dr. Mandeep Mehra of Brigham and Women's Hospital in Boston led both the Lancet and NEJM studies and the authors in both cases include Sapan Desai, Surgisphere's founder.
Reacting to the latest developments, physician-scientist Eric Topol tweeted, "If authors misrepresent that they had full access to the data, there isn't any way to verify or refute that. The system relies on trust."
Standing up for the editors and peer reviewers at @TheLancet and @NEJM which retracted the papers today.
If authors misrepresent that they had full access to the data, there isn't any way to verify or refute that.
The system relies on trust.— Eric Topol (@EricTopol) June 4, 2020
(IANS)
Read More:
Coronavirus Doesn’t Spread From Pregnant Mothers To Newborns
Coronavirus Vaccine Could Be Available This Year, Says UK Scientist
The WHO said the decision was in light of the evidence from the Solidarity Trial interim results.
"These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized Covid-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect," the WHO said in a press release, Xinhua reported.
But the organization said this decision applies only to hospitalized patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalised patients or as pre- or post-exposure prophylaxis for Covid-19.
The Solidarity Trial was established by the WHO in March to find an effective Covid-19 treatment for hospitalised patients. It was originally designed to have five trial arms, including standard or usual care provided to Covid-19 patients, remdesivir, lopinavir/ritonavir combined, lopinavir/ritonavir combined with interferon beta, and hydroxychloroquine or chloroquine.
By enrolling patients in multiple countries, the Solidarity Trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival.
(IANS)
Read More:
Covid-19: WHO Team To Visit China Next Week To Investigate Source Of SARS-Cov-2
WHO Says AstraZeneca, Modena Leading Vaccine Race