Washington: A clinical trial to evaluate the safety and effectiveness of hydroxychloroquine, an antimalarial drug, for the treatment of adults hospitalized with COVID-19 (coronavirus) have begun in the United States, according to a release of the National Institutes of Health (NIH) on Thursday.
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.
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.
US death toll crosses 16,500; 11% under 25 years testing positive: White House
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.
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.
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".