New Delhi: The RECOVERY (Randomised Evaluation of Covid-19 therapy) Trial at the University of Oxford is all set to test its first specifically designed Covid-19 therapy — REGN-COV2 — which is a cocktail of antiviral antibodies.
Antibodies are protein molecules that are present in the plasma, the matrix of the blood in which the cells float, and are designed to act against specific invading pathogens.
In a statement issued Monday, the university said: “The University of Oxford and Regeneron Pharmaceuticals, Inc. today announced that RECOVERY, one of the world’s largest randomised clinical trials of potential Covid-19 treatments, will evaluate Regeneron’s investigational antiviral antibody cocktail, REGN-COV2.”
“The Phase 3 open-label trial in patients hospitalised with Covid-19 will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own,” it added. An open label trial is one in which all participants know which arm of the trial they are in.
The RECOVERY trial is one of the biggest trials that is currently looking for therapeutic options against Covid-19.
It started with six arms — Lopinavir-Ritonavir (a commonly used second line drug to treat HIV, which has now been stopped), low-dose Dexamethasone (this arm is currently only recruiting children), Hydroxychloroquine (now stopped), Azithromycin (a commonly used antibiotic), Tocilizumab (an anti-inflammatory treatment given by injection) and convalescent plasma (collected from donors who have recovered from Covid and contains antibodies against the SARS-CoV-2 virus).
REGN-COV2 will be a new arm of the trial.
Positive results found earlier in Dexamethasone
Chief investigator of the trial, Peter Horby, who is the professor of Oxford’s Emerging Infectious Diseases and Global Health, Nuffield Department of Medicine, said: “We have already discovered that one treatment, Dexamethasone, benefits Covid-19 patients, but the death rate remains too high, so we must keep searching for others.”
“The RECOVERY trial was specifically designed so that when promising investigational drugs such as REGN-COV2 became available, they can be tested quickly. We are looking forward to seeing whether REGN-COV2 is safe and effective in the context of a large-scale randomised clinical trial. This is the only way to be certain about whether it works as a treatment for Covid-19,” he added.
Clinical trials of REGN-COV2 began in mid-June.
A phase 3 clinical trial on the preventive functions of REGN-COV2 in Covid is being jointly conducted by Regeneron with the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health.
“The world urgently needs new medicines to combat Covid-19, and well-designed trials to evaluate new treatment options will quickly help us learn which are most effective. REGN-COV2 was specifically designed by Regeneron scientists to target the virus that causes Covid-19,” said George D. Yancopoulos, MD and PhD, president and Chief Scientific Officer of Regeneron.
“RECOVERY will be the fourth late-stage randomised clinical trial evaluating REGN-COV2 and will add to our knowledge about how this novel antibody cocktail may help hospitalised patients in need,” he added.
First specifically designed Covid therapy
Oxford said REGN-COV2 is the first specifically designed Covid-19 therapy being evaluated by RECOVERY.
According to the statement, the drug cocktail was selected in part based on its emerging safety profile in humans and pre-clinical data showing it could protect against viral escape mutations that help a virus evade antibodies. Further, prevention and treatment studies in non-human primates showed it reduced the amount of virus and associated damage in the lungs.
REGN-COV2 is currently being studied in two Phase 2/3 clinical trials for the treatment of Covid-19 and in a Phase 3 trial for the prevention of Covid-19 in household contacts of infected individuals, the statement added.
The therapy is likely to be tested on 4,000 patients with those randomly assigned to either the trial group or the control group, which will receive standard care and be evaluated 28 days later.
Martin Landray, professor of Oxford’s Medicine and Epidemiology, Nuffield Department of Population Health, said: “Throughout the Covid-19 pandemic, we have seen the power of randomised trials to provide rigorous assessment of potential treatments.”
“Up to now, we have largely been studying whether existing drugs can be repurposed to tackle this new disease, but we now have the opportunity to rigorously assess the impact of a drug specifically designed to target this coronavirus.”
“There are good reasons to be excited about this new development — RECOVERY will provide a robust assessment of the effect of this lab-manufactured monoclonal antibody combination treatment in hospitalised patients,” he added.
The trial is being coordinated by researchers at the University of Oxford, which acts as the sponsor for the research, working with clinical teams at 176 hospital sites across the UK.
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