The UK started human studies on Monday of a new antibody treatment for patients hospitalized with COVID-19.
As part of the government-sponsored randomized evaluation of COVid-19 THERAPY (RECOVERY) trials, approximately 2,000 patients will be given monoclonal antibodies or potent laboratory-made antibodies over the coming weeks to see if they are effective against coronavirus.
The Phase 3 open-label study in patients admitted to hospital with COVID-19 compares the effects of adding REGN-COV2 to the usual standard of care versus the standard of care alone.
“REGN-COV2 was specifically designed by Regeneron scientists to fight the virus that causes COVID-19. RECOVERY will be the fourth late-stage randomized clinical trial to evaluate REGN-COV2 and expand our knowledge of how this novel antibody cocktail in the hospital can help patients in need, “said George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, the biotech company working on the project.
“The world desperately needs new drugs to fight COVID-19, and well-designed studies evaluating new treatment options will quickly help us figure out which are most effective,” he said.
Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine at Oxford University, is the study’s lead researcher.
He said the study aims to determine whether REGN-COV2 is safe and effective in a large-scale randomized clinical trial.
“We have already determined that one treatment, dexamethasone, will benefit COVID-19 patients, but the death rate remains too high so we will have to keep looking for others. The RECOVERY study was specifically designed to identify promising investigational drugs such as REGN-COV2 available to develop they can be tested quickly, “he said.
REGN-COV2 is the first specially developed COVID-19 therapy that is being evaluated by RECOVERY.
Experts said it was due to its emerging safety profile in humans, preclinical data showing it can protect against viral escape mutations, and prevention and treatment studies in non-human primates that showed it could reduce the amount of virus and the harm it causes in the lungs.
Professor Fiona Watt, executive chairman of the UK Medical Research Council, stressed that the RECOVERY study previously found the “most clinically effective” treatment for COVID-19 in dexamethasone.
“The same UK study is now testing a new treatment specifically designed to fight the virus that causes the disease. Monoclonal or targeted antibodies are already being used to treat cancer and autoimmune diseases.
“The new study will show us whether antibodies that attack the virus can be an effective treatment for COVID-19,” she said.
Martin Landray, professor of medicine and epidemiology in the Nuffield Department of Population Health at Oxford University, said there are good reasons to be excited about the studies, as it would provide a solid estimate of the effects of the laboratory-made combination monoclonal antibody treatment on hospital patients.
“So far, we’ve done a lot of research into whether existing drugs can be reused to fight this new disease, but we now have the opportunity to accurately assess the effects of a drug specifically designed to fight this coronavirus,” he said.
REGN-COV2 is currently being investigated in two phase 2/3 clinical studies for the treatment of COVID-19 and in a phase 3 study for the prevention of COVID-19 in household contacts of infected people.
The open-label RECOVERY study evaluates the effects of adding REGN-COV2 to the usual standard of care on all-cause mortality 28 days after randomization. Other endpoints include the impact on hospitalization and the need for ventilation.