By Thomas M. Burton 

WASHINGTON -- The National Institutes of Health on Tuesday said it is launching wide-ranging studies of potential Covid-19 drugs known as monoclonal antibodies, the synthetic targeted versions of proteins produced by recovered Covid-19 patients.

The potential drugs that emerge from the research could be among the foremost medical treatments to prevent or treat infections with the new coronavirus while the U.S. and world await possible vaccines. Anthony S. Fauci, who heads the NIH institute overseeing the work, said monoclonal antibodies have great potential because they are specifically designed to block the virus from infecting a human cell.

The National Institute of Allergy and Infectious Diseases, led by Dr. Fauci, is sponsoring the clinical trials, which are part of a government-industry collaboration known as ACTIV, for Accelerating Covid-19 Therapeutic Interventions and Vaccines.

The beginning steps of the work will focus on one monoclonal antibody from Eli Lilly & Co., called LY-CoV555, but are expected to broaden to studies of a series of monoclonal antibodies and even other antiviral drugs.

The first of two studies will initially involve 220 patients with moderate disease who don't require hospitalization. Half will get the Lilly drug, and half will get an intravenous saline placebo. The study could expand to study other investigational drugs.

The beginning stage of the trial will evaluate safety. If safety is demonstrated, the study will convert into assessing the drug in a total of 2,000 patients. The goal is to see if people can avoid hospitalization or death by day 28 of the trial.

The second study will evaluate the Lilly drug, and later other agents, in hospitalized patients. Dr. Fauci said results from the trials are expected by late October or early November.

Lilly is separately studying its drug to see if it can prevent Covid-19 infections among long-term-care residents.

Part of the funding for the ACTIV work will come from the government's Operation Warp Speed, a cross-agency effort that is spending billions of dollars to quickly ramp up drug and vaccine production for Covid-19. The disease already has killed more than 155,000 people in the U.S., according to data Tuesday from Johns Hopkins University.

"We're looking for big impact in disease," said Janet Woodcock, a senior Food and Drug Administration official detailed to Operation Warp Speed during the pandemic.

Government officials declined to specify during a press call how many therapeutic agents will be studied in the ACTIV trials. NIH Director Francis Collins said he expects there will be "several," with government officials trying to identify "the highest priorities with the best science."

 

(END) Dow Jones Newswires

August 04, 2020 13:55 ET (17:55 GMT)

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