Developed by US-based drug company Merck, Molnupiravir is approved by the US Food and Drug Administration against Covid-19. It is approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of mild-to-moderate Covid-19 in adults with a high risk of progression to severe disease, mainly those with pre-existing (comorbid) conditions.
India has also approved the drug amid rising cases of new Covid variant Omicron in India. An expert panel of the Central Drugs Standard Control Organisation had recently approved the antiviral Molnupiravir for restricted use in emergency situations. The antiviral drug will be manufactured by 13 companies in India.
However, Indian Council of Medical Research (ICMR) Director General, Balram Bhargava, said that the Molnupiravir is not included in the national Covid taskforce treatment as it has major safety concerns like teratogenicity, mutagenicity, muscle and bone damage among others.
"More importantly contraception has to be done for three months if this drug is given for male and female as the child born could be problematic with teratogenic influences," he said at a press briefing.
Medical experts, on the other hand, have pointed out that the benefits of the drug outweigh the potential risks it may have in the case of high-risk patients.
But they say as there are very limited options of medicines to treat Covid patients, hence the new approved medicines should be given a try under strict treatment regime protocols.
"Physicians have to keep in mind their patient profiles while prescribing any drug. If the patient is high-risk that is more than 60 years of age, is obese or having cardiovascular disease, hypertension, and/or has chronic lung or kidney or liver disease, then not treating when the disease is mild or moderate can take extreme turns, putting the patient in risk of hospitalisation and as we have seen at the time of Delta variant, even possible death," said Dr Deepak Talwar, Senior Consultant, Pulmonology and Sleep Medicine, and Chairman, Metro Respiratory Centre.
"We have to use the available therapy rather than counting its side-effects, that too which are potential, but not known," he added.
According to Dr Dhruva Chaudhry, Head - Pulmonary and Critical Care Medicine at PGIMS, Rohtak, while giving approval, the US FDA as well as the DCGI have gone through the safety data of the drug. "Only once satisfied, this drug has been approved."
"Even in the phase 3 clinical trials Molnupiravir demonstrated a significant reduction in the risk of hospitalisation or death with no observed safety concerns when compared to the placebo group," Chaudhry said.
Molnupiravir inhibits the replication of certain RNA viruses. It is basically to be used in treating Covid-19 infected people of more than 50 years of age and in those with multiple comorbidities. The recommended dose of Molnupiravir 800 mg is twice a day for five days. A patient needs to take 40 capsules containing 200 mg of medication.
Over a dozen pharma companies including Torrent, Cipla, Sun Pharma, Dr Reddy's, Natco, Mylan, and Hetero are in the process to manufacture the oral pill. Cipla, Sun Pharma, and Dr Reddy's Laboratories are also expected to release Molnupiravir capsules in the coming weeks.
During the second surge of Covid infections in the country, the percentage of active cases that needed hospital care were in the range of 20-23 per cent, Union Health Secretary Rajesh Bhushan said in a letter to states and Union territories.
The rise in COVID-19 cases in various parts of the country appears to be driven by the Omicron variant as well as by the continued presence of Delta, he said and stressed on augmenting human resources, particularly healthcare workers, for Covid management.
"In the present surge, five to 10 per cent of active cases needed hospitalisation so far. The situation is dynamic and evolving. Therefore, the need for hospitalization may also change rapidly," Bhushan said.
All states and Union Territories are advised to keep a daily watch on the situation of the total number of active cases, cases under home isolation, the number of hospitalized cases, cases on oxygen beds, ICU beds and on ventilatory support, he wrote.
"Based on this monitoring, the requirement of healthcare workers and their availability health facility wise must also be reviewed daily as was done during the second surge," the health secretary said.
Appreciating that while various states and Union Territories initiated steps for the establishment of jumbo health facilities, field hospitals, temporary hospitals among others, Bhushan said both infrastructure and human resources have their limitations.
Therefore, it is important to conserve healthcare workers by initiating staggering wherever possible and by restricting elective procedures in the hospitals, he advised.
It is also important to strictly follow the advisory, issued by the Health Ministry on January 9, for managing healthcare workers in Covid and non-Covid areas of healthcare facilities.
The ministry has suggested states and Union Territories to earmark different categories of beds in private clinical establishments for Covid care.
"It must also be ensured that charges levied by such health facilities are reasonable and there is a mechanism to monitor and initiate action in cases of over-charging if any," Bhushan said in the letter.
He also suggested engaging retired medical professionals or MBBS students for teleconsultation services and providing skill training of community volunteers in basic care and management at Covid Care Centres.
The health secretary also suggested requisition of additional ambulances or private vehicles to improve referral transport and facilitate seamless transfer of COVID-19 cases from home isolation or from Covid Care Centres to Covid Dedicated Hospitals.
All district hospitals and medical college hospitals should be used as eSanjeevani teleconsultation hubs. Requisite financial resources for this have already been provided under ECRP-II to states and Union Territories, Bhushan said in the letter.
The figures were revealed during a review meeting on the COVID situation in the State by Chief Secretary Suresh Mohapatra.
The discussions in the meeting showed that a total number of 7181 oxygen-supported beds, around 1000 pediatric beds, 2024 ICUs and HDUs, and 874 ventilators were already made available in all districts.
Rapid Response Teams have been deployed to monitor the home isolation cases. Similarly, only around 3% of the available beds, 11% of the ICUs, and 3% of the ventilators are being used in the State.
Chief Secretary directed to insulate the doctors, nurses, and health workers detailed for Covid duty with booster dose on priority basis and also asked the officials to ensure all Covid hospitals and Care Centers put in place help desk system for communication with family members and relatives of the patients.
Health and Family Welfare Additional Chief Secretary Raj Kumar Sharma said that all facilities and provisions put in place for combating the second wave of the pandemic should be reactivated with full force. He also asked the Collectors to recruit the retired doctors and nurses locally as per the requirement. The CDMOs and Public Health officers were asked to go ahead with booster dose vaccination with the already available vaccines in all districts.
Chief Secretary Suresh Mahapatra also directed the Collectors to visit all Covid hospitals personally and look into the arrangements like availability of medicine, manpower, instruments, pathological test facilities, oxygen, seamless admission of the patients, proper treatment, trained doctors, nurse and health workers communication with family members of the patients.
According to principal investigator Gordon Saxe, director of research at the Center for Integrative Health in University of California-San Diego, mushrooms were chosen because of their long history of use and recent evidence of immune-enhancing and antiviral effects.
MACH-19 (Mushrooms and Chinese Herbs for Covid-19) is a multi-centre study led by UC San Diego's School of Medicine and UC-Los Angeles, in collaboration with the La Jolla Institute for Immunology.
In a preclinical study published in 2019, mushroom agarikon was found to inhibit viruses, including influenza (H1N1), influenza A (H5N1) and herpes. Saxe said he believes medicinal mushrooms inhibit the viruses' replication, a theory he plans to test against SARS-CoV-2 in a Phase II trial.
"Mushrooms have the advantage that they co-evolved with us. So bacteria, viruses and other fungi prey on mushrooms just like they prey on humans. And mushrooms have developed exquisite defenses against those pests, and we believe they can confer those to us when we eat them," Saxe said.
MACH-19's third ongoing trial measures whether the same medicinal mushrooms, given in capsules at the time of initial Covid vaccination, can increase antibodies and other measures of immune response.
A fourth trial, yet to be launched, will look at whether medicinal mushrooms could provide a similar lift to Covid-19 booster shots as an adjuvant, a substance which enhances immune response.
"Vaccines lead to the production of antibodies that can destroy the virus in the blood," Saxe said.
"Mushrooms may not only increase the number of these antibodies, but also enhance T-cell immunity against virally infected cells. Further, because mushrooms bind to receptors on human immune cells, they can modulate our immunity -- boosting it in some ways and calming it down in others. And this property of mushrooms may also reduce vaccine-related side effects.
Natural therapeutics have been used for centuries to treat infectious diseases, according to Saxe, who noted that herbs helped Chinese doctors manage 300 recorded epidemics, while the Greek pharmacologist Pedanius Dioscorides prescribed agarikon to treat pulmonary infections 2,300 years ago.
The three trials, under MACH-19 of which two are Food and Drug Administration (FDA)-approved, are currently recruiting for between 66 and 80 patients who have tested positive for SARS-CoV-2 and who are quarantined at home with mild to moderate symptoms.AInitial safety data from the trials are expected by the end of this year, with efficacy data ready within a year.
Statins are a recommended and common intervention for preventing cardiovascular events by reducing levels of lipoprotein cholesterol in the blood.
To understand the link, researchers at Karolinska Institutet in Sweden followed 9,63,876 residents of Stockholm above the age of 45 between March and November 2020.
The results published in PLOS Medicine showed that statin treatment was associated with a slightly lower risk of dying from Covid-19, a correlation that did not vary significantly among risk groups.
"Our results suggest that statin treatment can have a moderate prophylactic effect on Covid-19 mortality," said Rita Bergqvist, Medical student at Karolinska Institutet.
"All in all, our findings support the continued use of statins for conditions such as cardiovascular disease and high levels of blood lipids in line with current recommendations during the Covid-19 pandemic," Viktor Ahlqvist added, Doctoral student at the Department of Global Public Health, Karolinska Institutet.
However, this finding needs confirmation from randomised clinical trials, the researchers said.
Hyperinflammation and hypercoagulability have been identified as central to the development of severe Covid-19 disease and complications. Hence, drugs that modulate the host immune response and inhibit thrombosis and vascular dysfunction have received widespread attention.
Hyperinflammation is uncontrolled, self-perpetuating and tissue-damaging inflammatory activity while Hypercoagulability can be defined as the tendency to have thrombosis as a result of certain inherited and/or acquired molecular defects.
One limitation of the study concerns the use of prescription data without the possibility of checking individual drug use. The researchers were also not able to control for risk factors such as smoking and high Body Mass Index, only diagnosed health status.
Gout is a type of arthritis characterised by severe pain, redness and tenderness in joints.
The study, published in the journal Scientific Reports, found that 'probenecid' has broad anti-viral properties, making it a prime candidate to combat not only SARS-CoV-2 infection but also other common and deadly respiratory viruses like RSV and flu.
FDA approved probenecid has been on the market for over 40 years and has minimal side effects.
"There's really nothing out there to safely fight these viruses," said lead author Ralph Tripp from University of Georgia's College of Veterinary Medicine.
"This antiviral works for all RNA respiratory viruses we tested, including SARS-CoV-2. RSV, coronavirus and flu all circulate in the same season. Bottom line is you can potentially reduce infection and disease using this one oral drug," Tripp added.
Viruses work by co-opting a person's own cells to replicate and produce more of the virus. Probenecid blocks that replication process, keeping the virus from infecting the individual's cells.
In clinical development, Tripp showed the drug works as a prophylactic prior to virus exposure and as a post-exposure treatment in animal models against SARS-CoV-2 and flu. The drug also has proven effective in fighting the RSV in vitro, and in vivo studies are in progress.
Although the drug would primarily be used after a person is positive for the virus, the prophylactic findings mean people with known exposures could also potentially take the drug to prevent getting sick.
The current go-to treatments for seriously ill Covid-19 patients, remdesivir and monoclonal antibodies, can only be given through an IV. And by the time a Covid patient needs them, it's often too late.
"These treatments have seen some effectiveness against SARS-CoV-2, but they're very expensive and very hard to come by," Tripp said. "In reality, there are only a handful of options that can actually be used because of the cost, restricted IV usage, and lack of access. That's not very useful to the world."
Probenecid, on the other hand, is widely available. Primary care physicians could prescribe a pill to patients, and they could pick it up at their local drugstore.
Now the researchers are investigating what dosage of probenecid could have the biggest impact fighting viruses in people.
The US Food and Drug Administration (FDA) had, in April last year, warned against the use of ivermectin, due to the lack of supporting scientific evidence.
Ivermectin is not an anti-viral (a drug for treating viruses), but has been approved at very specific doses for some parasitic infections like intestinal strongyloidiasis and onchocerciasis, head lice, or skin conditions like rosacea.
"You are not a horse. You are not a cow. Seriously, y'all. Stop it," the FDA said in a tweet on Saturday.
The new warning came a day after the Mississippi State Department of Health issued a similar statement in response to reports that an increasing number of people in Mississippi were using the drug to prevent a Covid infection, the New York Times reported.
"At least 70 per cent of the recent calls have been related to ingestion of livestock or animal formulations of ivermectin purchased at livestock supply centers," the Department said in a statement.
"Animal drugs are highly concentrated for large animals and can be highly toxic in humans. Some of the symptoms associated with ivermectin toxicity include rash, nausea, vomiting, abdominal pain, neurologic disorders, and potentially severe hepatitis requiring hospitalisation," it added.
In March, the World Health Organisation had also recommended against the use of ivermectin in treating Covid patients. The WHO said there was a "very low certainty of evidence" on ivermectin's effects on mortality, hospital admission and getting rid of the virus from the body.
"Safety and efficacy are important when using any drug for a new indication. WHO recommends against the use of ivermectin for #Covid19 except within clinical trials," Soumya Swaminathan, the global health body's chief scientist, said in a tweet.
Covid-19 treatment guidelines issued by the National Institutes of Health (NIH) also states that "there is insufficient evidence for the Covid-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of Covid-19."
However, ivermectin has been taken up by doctors and by individuals self-medicating in countries, including Brazil, Bolivia, Peru and South Africa.
The FDA said that it has not reviewed data to support use of ivermectin in Covid-19 patients to treat or to prevent Covid-19. However, some initial research is underway.
But, "taking a drug for an unapproved use can be very dangerous. This is true of ivermectin, too.
"There's a lot of misinformation around, and you may have heard that it's okay to take large doses of ivermectin. That is wrong," the FDA said.
The team from National University of Singapore (NUS) found that a combination of antiviral molnupiravir and anti-inflammatory baricitinib can be effective against the Beta and Delta variants of the virus, the Strait Times reported.
The combination could strongly inhibit the SARS-CoV-2 virus in laboratory tests, making it suitable for further clinical evaluation, Professor Dean Ho, director of the NUS's Institute for Digital Medicine, was quoted as saying.
"... we are looking for combination therapies that can eventually be given to patients with mild illness who are recovering at home, or in community care facilities," Ho said.
Experts from the National Centre for Infectious Diseases, NUS Medicine and the National University Hospital (NUH) tested 12 drugs -- which included a range of antivirals and cancer drugs.
The molnupiravir-baricitinib combination was identified for possible treatment, the report said.
However, there is no data yet from clinical trials that show the drug combination is effective in all phases of Covid-19 disease, Dr Louis Chai, a senior consultant at the NUH Division of Infectious Diseases, was quoted as saying.
While some drugs could reduce the Covid viral load in patients, they may not slow down disease progression or prevent death, he noted.
Molnupiravir "interferes with a part of the virus that is conserved across different variants -- specifically, the enzyme that it uses to copy its genetic material for replication", said Dr Conrad Chan, laboratory director at the Defence Medical and Environmental Research Institute from DSO.
Chan molnupiravir "a strong 'backbone' drug candidate from which multiple combinations can be derived", he added.
Ho said his team is now looking to conduct clinical trials for molnupiravir and its drug combinations on Covid-19 patients. Vaccinated individuals with mild to moderate disease could be considered as part of the study cohort, the report said.
Both the institutions signed a Memorandum of Understanding to conduct the clinical trials of Ashwagandha on 2,000 people in three UK cities -- Leicester, Birmingham, and London (Southall and Wembley), said the ministry in a statement.
Ashwagandha (Withania Somnifera), commonly known as 'Indian winter cherry', is a traditional Indian herb that boosts energy, reduces stress, and makes the immune system stronger.
It is an easily accessible, over-the-counter nutritional supplement in the UK and has a proven safety profile. The positive effects of Ashwagandha have been observed in Covid, which is a multi-system disease with no evidence of its effective treatment or management.
The successful completion of the trial can be a major breakthrough and give scientific validity to India's traditional medicinal system. While there have been several studies on Ashwagandha to understand its benefits in various ailments, this is the first time the Ministry has collaborated with a foreign institution to investigate its efficacy on Covid-19 patients.
AIIA director Dr Tanuja Manoj Nesari, who is also a co-investigator in the project along with Dr Rajgopalan, Coordinator - International Projects, said that the participants have been randomly selected. Dr Sanjay Kinra of LSHTM is the principal investigator of the study.
The participants will have to take the 500mg tablets twice a day. A monthly follow-up of self-reported quality of life, impairment to activities of daily living, mental and physical health symptoms, supplement use and adverse events will be carried out.
"For three months, one group of 1,000 participants will be administered Ashwagandha (AG) tablets while the second group of 1,000 participants will be assigned a placebo, which is indistinguishable from AG in looks and taste. Both patients and the doctors will be unaware of the group's treatment in a double-blind trial," Dr Nesari said.
As per available data, Capital City Bhubaneswar has 1494 active cases by July 20 of which 801 (more than 50 per cent) are under treatment in different hospitals. Of the total hospitalised patients, 552 are in ICU while 99 under ventilator support.
The situation in the Silver City Cuttack is also alarming. The Cuttack Municipal Corporation (CMC) accounts for 1220 active cases of the total 2,559 active cases in the district. Out of the total active cases, 1028 are undergoing treatment in hospitals.
However, what is more worrisome is that 593 patients are in ICUs while the total ICU strength is 853. Similarly, 131 of the total ventilator beds are occupied. While 70 per cent ICU beds are occupied, only 22 per cent ventilator beds are vacant.
DMET Chief Dr CBK Mohanty said, “We cannot say that the rate of infection did not decline in the Twin City. Definitely the cases have declined if we compare the situation of three-four weeks back.”
He said Bhubaneswar and Cuttack are administrative, business and health hubs. Therefore, the number of cases is high in both the cities.
Additional Commission of Bhubaneswar Municipal Corporation, Laxmikant Sethi said, “The number of Covid patients is high in Bhubaneswar, but that does not mean all of them are from the city. As there is massive influx of people to Bhubaneswar from other places in the State, the number seems bigger.”
Informing about the arrival of the machine, Sachidananda Mohanty (Medical Superintendent), Bhubaneswar AIIMS, said that the first ECMO machine arrived at AIIMS, Bhubaneswar on July 29.
"Installation process of the ECMO machine is going on. We are preparing to make it functional very soon, and, maximum by our foundation day (July 15)," informed Mohanty.
Once the machine becomes functional, many poor people of Odisha will be benefitted, he said.
He further said that the second ECMO machine is likely to come very soon, may be by July 15.
The Odisha government has already decided to install six such life-saving equipment at the SCB Medical College and Hospital in Cuttack, and also at Capital Hospital in Bhubaneswar.
ECMO machine is used when all other medical options are exhausted for a patient when his/her lungs can’t provide enough oxygen to the body. It is also used for patients whose heart can’t pump enough blood to the body.
Health experts claim that four out of 10 COVID patients are getting cured by the ECMO treatment.
Mishra said that steroids are being used in Covid-19 treatment as per the guidelines. At present those are being used only for the treatment of moderate to severe cases of Covid-19.
"Steroids are being used in cases of Covid-19 patients who are moderately infected or critically ill and for those who require oxygen or ventilator support. Steroids will have no impact or is not required to treatment mild cases," said Mishra.
While responding to a query in the third wave of Covid-19, Mishra said already several countries across the world are facing the third wave.
As of now, there are predictions regarding the third wave and the Odisha government is in full prepardness mode to deal with any emerging situation in the future.
"It is observed that the impact of third wave is much low compared to second wave of Covid-19 pandemic. However, the State government is ready and everybody needs to be cautious. Everyone should keep following the Covid appropriate behaviour," said Mishra.
Mishra further stressed speeding up the vaccination process before the third wave hits Odisha.
"The entire vaccination process depends on how much vaccines are provided by the Centre. The vaccination drive will be taken up as per the stock supplied to us. However, the State government has made elaborate plans and readied infrastructure for the Covid-19 vaccination drive," Mishra added.
The trial is a multi-centric, randomised, open label clinical study to evaluate efficacy, safety and tolerability of NIclosamide for the treatment of hospitalized Covid-19 patients, it said.
Niclosamide has been extensively used in past for treatment of tapeworm infection in adults as well as children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels.
CSIR Director General Shekhar C. Mande expressed his happiness over the SEC recommendations to conduct this Phase II clinical trial using Niclosamide, which is a generic and affordable drug, easily available in India, and therefore, can be made available to the population.
CSIR-IICT Hyderabad Director Srivari Chandrashekhar highlighted that the Active Pharmaceutical Ingredient (API) is being made by Laxai Life Sciences based on improved technology developed at the IICT and the lab is a partner in this important clinical trial which could provide cost effective therapeutic options for patients if trial is successful.
Laxai CEO, Dr Ram Upadhayaya, said that realising the potential of Niclosamide, efforts were initiated last year itself to undertake clinical trials. Having received approval from drug regulator, the clinical trial has been initiated this week at different sites and is expected to be completed within 8-12 weeks. Based on successful clinical evidence generated during clinical trials in Indian studies, emergency use authorisation may be sought so that more treatment options are available to COVID-19 patients, he said.
The SCB Medical College on Saturday formed the 3 teams for Bhubaneswar, each comprising two doctors and one other team with two members to conduct inspection at Covid hospitals in Cuttack.
Sources said the teams will visit the hospitals everyday and verify the extent of treatment required and health status of patients admitted in ICUs.
Patients having no requirement of critical support would be shifted to other wards so that other needy patients can be allotted the beds.
The government's decision comes in the backdrop of several reports claiming patients unnecessarily occupying ICU beds at various hospitals while many people who are in dire need of the critical life support are denied the facility.
As per Odisha Government sources, around 21 per cent of the ICU beds are vacant in the State which means the high active caseload and report of thousands of new cases are well on course to overwhelm the health infrastructure in the State.
However, the government claims that it is ready to face all eventualities and save lives of the public from the pandemic.
Anesthesiologist Arun Kumar Sahu and Medicine Specialist Pranay Kumar Patro have been roped in for the inspection exercise in Cuttack.
Similarly, doctors Kamalakant Pradhan, Rabindra Kumar Kisku, Kamala Kanta Swain, Dipti Ranjan Darji, Avijeet Swain and Sridhar Panda have been divided into 3 groups for Bhubaneswar.
The study, led by researchers from Wayne State University in Detroit, US, revealed elevated levels of specific biomarkers of the immune system compared to those who were not infected with coronavirus.
In addition, levels of these inflammatory markers were higher in patients with comorbidities such as high blood pressure and diabetes.
Researchers said they undertook this study in hopes of determining whether biomarkers of Covid-19 could predict which individuals will develop “overly exuberant immune responses,” also called a cytokine storm.
They chose to screen the urine of Covid-19 patients because of its non-invasive nature that doesn’t require the use of needles or blood samples.
Scientists said they hope the results of this study will translate to a regular screening process for Covid-19 patients to predict who is more likely to develop severe disease and to aid in a successful treatment strategy.
The findings will be presented virtually at the American Physiological Society’s annual meeting at Experimental Biology 2021.
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)
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According to sources, these committees will audit the treatment provided at both government and private hospitals across the State and deaths reported due to the SARS-nCoV. Moreover, the committee will examine the full medical records of the patients.
The committee will be formed in every district and an officer authorised by the district collector or municipal commissioner will head the body. However, an officer, lower than the rank of Additional District Magistrate (ADM) cannot head the committee, sources added.
The committee will be comprised of Chief District Medical Officer (CDMO), ICU trained doctor and medical officer of COVID hospital.
Notably, Odisha so far has reported 2, 49,693 COVID 19 cases of which 24,361 are still active cases. While 2,24,273 patients recuperated from the diseases, the virus has claimed 1,006 lives in the State.
(Edited By Suryakant Jena)
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Over 3800 Cured Of COVID-19 In Odisha; Total Recoveries At 224273
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The emergency use authorisation is for the antibody cocktail casirivimab and imdevimab to be administered together -- also known as REGN-COV2 or REGEN-COV2 -- for recently diagnosed, mild to moderate Covid-19 in high-risk patients, the FDA said late on Saturday.
Regeneron said that it is the first treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2, the virus responsible for Covid-19.
Casirivimab and imdevimab administered together are authorised for the treatment of mild to moderate Covid-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at a high risk for progressing to severe Covid-19 and/or hospitalisation.
The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load, the company said.
"This FDA Emergency Use Authorisation is an important step in the fight against Covid-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection," Leonard Schleifer, President and Chief Executive Officer of Regeneron, said in a statement.
"The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximise production of REGEN-COV2. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need."
Production of monoclonal antibodies is a complex, time- and labour-intensive process that requires deep expertise.
Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 2,00,000 patients by the first week of January, and approximately 3,00,000 patients in total by the end of January 2021.
(With IANS Inputs)
They reviewed the ongoing public health measures of surveillance, containment and management of COVID cases in wake of the steep rise in daily new cases of COVID and the high number of active caseload being reported from these eight States/UTs.
In a detailed presentation, it was pointed out that 9 districts in Delhi, 15 in Haryana, 10 in Andhra Pradesh, 10 in Odisha, 9 in Himachal Pradesh, 7 in Uttarakhand, 2 in Goa, 1 in Chandigarh continue to be of concern as these districts are seeing a decrease in total tests being conducted, low share of RT-PCR tests, increase in weekly positivity and low number of contact tracing of the COVID positive cases. These together can pose high risk of transmission to the neighbouring States and UTs. A granular analysis of the COVID response in the districts was shared with the States/UTs for further action.
States were specifically asked to:
Stress was laid on prompt isolation and on medical supervision of those active cases presently in home isolation for early identification of progressive deterioration of the disease. The States were also asked actively watch out for super-spreading events and share their best practices in breaking the chain of transmission.
(PIB)