RECOVERY trial to test REGN-COV2

Oxford University to conduct a RECOVERY trial to test REGN-COV2 

The University of Oxford is all set to test the RECOVERY(Randomised Evaluation of COVID-19 therapy) Trial – the first specifically designed COVID-19 therapy – a cocktail of antiviral antibodies- REGN-COV2.

The protein molecules present in the plasma which are designed to act against particular invading pathogens are called Antibodies.

The Oxford University and Regeneron Pharmaceuticals, Inc. announced that RECOVERY, one of the world’s largest randomized clinical trials of prospective COVID-19 therapies, will certainly assess Regeneron’s investigational REGN-COV2 – antiviral antibody cocktail said the university.

In the statement, the university also stated that the phase 3 open-label trial (in which all participants recognize which arm of the test they are in) in hospitalized COVID-19 people will certainly compare the effects of adding REGN-COV2 to the common standard-of-care against standard-of-care on its own.

The Randomised Evaluation of the COVID-19 therapy trial is one of the largest trials that is presently seeking therapeutic alternatives for COVID-19 infection.

This trial began with six arms – convalescent plasma (collected from donors who have recuperated from COVID-29 and has antibodies against the SARS-CoV-2), Lopinavir-Ritonavir (a commonly utilized 2nd line medicine to deal with HIV, which has

currently been stopped), Hydroxychloroquine (now stopped), Azithromycin (a commonly used antibiotic), Tocilizumab (an anti-inflammatory drugs given by injection) and low-dose Dexamethasone (this arm is presently used only in recruiting children).

The new arm of this trial will be REGN-COV2.

Earlier dexamethasone showed positive outcomes

It is already uncovered that treatment, Dexamethasone, helps COVID-19 patients, however, the death rate stays high, so we must keep looking for other alternatives, said Peter Horby, Chief investigator of the trial, the professor of Oxford’s Emerging Infectious Diseases and Global Health, Nuffield Division of Medicine.

He added that the RECOVERY trial was particularly created to ensure that when promising investigational medications such as REGN-COV2 appeared, they can be examined immediately. In the context of a large randomized clinical trial, they are anticipating to see whether REGN-COV2 is safe and effective – the only way to be specific about whether it works as a COVID-19 treatment.

Regeneron with the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health will jointly conduct the phase 3 clinical trial on the preventive functions of REGN-COV2 in COVID-19 in mid-June.

George D Yancopoulos, MD and Ph.D., president and Chief Scientific Officer of Regeneron said that the world necessarily requires new medications to fight COVID-19, and well-designed trials to evaluate new treatment choices will rapidly aid us to find out which are most efficient. Regeneron scientists specifically designed REGN-COV2 to target the SARS-CoV-2.

He stated that the RECOVERY will certainly be the fourth late-stage randomized clinical trial reviewing REGN-COV2 and will certainly add in our knowledge regarding exactly how the hospitalized patient will be benefited by this novel antibody cocktail.

REGN-COV2 – Covid-19 therapy

REGN-COV2 is the first particularly designed COVID-19 treatment being evaluated by RECOVERY, claimed Oxford University.

The cocktail drug was chosen partially based upon its emerging safety profile in humans and pre-clinical information revealing it can protect against viral escape mutations that aid viruses escape antibodies. Additionally, prevention and therapy research studies in non-human primates showed it reduced the associated damages in the lungs and the amount of viruses.

The statement claimed that presently, REGN-COV2 is being studied in two Phase 2/3 clinical tests for COVID-19 treatment as well as in a Phase 3 trial for the prevention of COVID-19 infection in the infected people’s household contacts.

The treatment is most likely to be tested on 4,000 patients with those arbitrarily designated to either the trial or the control group, which will receive basic treatment as well as be assessed after 28 days.

Throughout the COVID-19 pandemic, they have seen the power of randomized trials to offer an extensive analysis of possible treatments, said Martin Landray, professor of Oxford’s Medicine and Epidemiology, Nuffield Department of Population Health.

He further added that that till now, they have largely been studying whether present medications can be repurposed to tackle this new disease, yet they now have the chance to extensively evaluate the influence of medicine specifically created to target SARS-CoV-2.

He stated that there are excellent reasons to be excited about this new development – RECOVERY will give a robust evaluation of the effect of this lab-manufactured monoclonal antibody combination therapy in COVID-19 hospitalized individuals.

The scientists at Oxford University are coordinating this clinical trial, and the Oxford University functions as the sponsor for the research study, dealing with clinical teams at 176 hospital sites throughout the United Kingdom.


Oxford University to conduct a RECOVERY trial to test REGN-COV2

Author: Sruthi S