The UK on Monday began a human trial of a new antibody treatment for patients hospitalized with COVID-19.
As part of a randomized evaluation of a government-backed COVID-19 therapy (RECOVERY) test, monoclonal antibodies, or potent laboratory-produced antibodies, approximately 2,000 patients will be given in the coming weeks to see if they are up against coronaviruses. Are effective.
A Phase 3 open-label trial in hospitalized patients with COVID-19 will compare the effects of adding REGN-COV2 to their own common standard-of-care versus standard-of-care.
“REGN-COV2 was specifically designed by Regeneron scientists to target viruses that cause COVID-19. RECOVERY will be the fourth late-stage randomized clinical trial evaluating REGN-COV2 and this knowledge antibody. Cocktails can help with hospitalization. Patients are in need, “said George de Yancopos, Regeneron’s president and chief scientific officer, a biotech firm collaborating on the project.
“The world needs new drugs to combat COVID-19 immediately, and well-designed trials to evaluate new treatment options will help us quickly learn which are the most effective,” he said .
Peter Horby, Professor of Emerging Infectious Diseases and Global Health at the University of Oxford’s Department of Newfield Medicine, is the principal investigator of the trial.
They stated that the study is aimed at determining whether REGN-COV2 is safe and effective in the context of a large-scale randomized clinical trial.
“We have already discovered that one treatment, dexamethasone, benefits COVID-19 patients, but the mortality is much higher, so we must keep searching for others. The RECOVERY trial was designed specifically So that when tested drugs such as REGN-COV2 became available they could be tested quickly, “he said.
REGN-COV2 is the first specially designed COVID-19 therapy being evaluated by RECOVERY.
Experts said pre-clinical data showing it was chosen because of its emerging safety profile in humans can protect against viral escape mutations, and studies of prevention and treatment in non-human primates showed It has been shown to reduce the amount of virus and associated damage. Lungs.
Professor Fiona Watt, acting president of the UK’s Medical Research Council, highlighted that the RECOVERY trial has previously found “the most clinically effective” treatment for COVID-19 in dexamethasone so far.
“The same UK-wide trial will now test a new treatment specifically designed to combat the virus that causes the disease. Monoclonal, or targeted, antibodies already used to treat cancer and autoimmune diseases Are done.
“New testing will tell us whether the virus-attacking antibodies can be an effective treatment for COVID-19,” she said.
Martin Landre, Professor of Medicine and Epidemiology, Newfield Department of Population Health, University of Oxford, said there are good reasons to be excited about the tests because it would provide a robust assessment of the effect of lab-produced monoclonloadic combination therapies. Hospitalized patient.
“So far, we are extensively studying whether existing drugs can be re-purposed to combat this new disease, but we now have a drug specifically designed to target this coronavirus Is an opportunity to rigorously assess the impact of. “
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 domestic contacts of infected individuals.
The open-label RECOVERY trial will assess the effect of adding REGN-COV2 to common standard-of-care on all normal mortality rates after 28 days of randomization. Other endpoints include hospital stay and impact on the need for ventilation.