Monoclonal antibody cocktail reduces the risk of death in severe cases of Covid-19, according to a randomized study. The monoclonal antibody treatment marketed by Cipla in India has been approved by the Central Drugs Standard Control Organization (CDSCO).
The treatment was developed by US biotechnology giant Regeneron in collaboration with Swiss pharmaceutical company Roche and uses a combination of two monoclonal antibodies – casirivimab and imdevimab. The antibody antibodies bind to two different sites on the SARS-CoV-2 spike protein and neutralize the virus’ ability to infect human cells.
Previous studies done on non-hospitalized Covid patients have shown that treatment with monoclonal antibodies reduces viral load, allows for faster symptom relief, and results in a significant reduction in the risk of hospitalization.
A randomized evaluation study now shows that Therapy with monoclonal antibodies reduces the risk of death in severe cases of Covid-19, when the patient’s body cannot build a natural antibody response on its own.
The study, dubbed “RECOVERY,” was the first study large enough to definitively determine whether this treatment reduced mortality in patients hospitalized with severe Covid-19. Preliminary results of the RECOVERY study are now being submitted to a leading peer-reviewed medical journal.
RECOVERY trial version
The study included a total of 9,785 patients who were hospitalized with Covid-19 between September 18 last year and May 22 this year.
A third of the patients were seronegative, which means that their bodies had not yet built a natural antibody response at the time of study entry. On the other hand, half were seropositive, meaning that their bodies had already developed natural antibodies.
At the time of the study, the antibody status was unknown in at least one sixth of the patients.
In addition to the usual treatment, these patients were randomly assigned the monoclonal antibody cocktail (4 grams each) Casirivimab and Imdevimab by intravenous infusion).
Treatment with monoclonal antibodies reduced the primary endpoint of 28-day mortality in seronegative patients by one-fifth compared to seronegative patients who received standard care only. This means that for every 100 patients treated with the antibody cocktail, there would be six fewer deaths.
In seronegative patients, the antibody cocktail shortened the hospital stay by four days. Compared to those who received only the usual care, the proportion of patients who were discharged alive up to the 28th day was also higher.
The study shows that the risk of ventilator reliance was also lower in seronegative patients who received treatment with monoclonal antibodies.
However, the effect of the treatment was different in seronegative and seropositive patients.
Antibody cocktail can lower mortality in late-stage Covid: Experts:
The joint chief researcher of the RECOVERY study, Sir Peter Horby, said: “These results are very exciting. The hope was that by giving a combination of antibodies to the SARS-CoV-2 virus, we would have the worst manifestations of Covid-19. However, there was great uncertainty about the value of antiviral therapies in late-stage Covid-19 disease. “
Horby, who is also Professor of Emerging Infectious Diseases at the University of Oxford’s Nuffield Department of Medicine, added, “It’s wonderful to learn that even with advanced Covid-19 disease, fighting the virus can lower patient mortality rates. who have failed to develop their own antibody response. “
The joint chief researcher of the RECOVERY study, Sir Martin Landray, said: “We now know that this combination of antibodies is not only bad for the virus, but also good for the sickest patients who have failed to develop their own natural immune response. “
“This is excellent news – it is the first time antiviral treatment has been shown to save lives in hospitalized COVID-19 patients. We are incredibly grateful to the many NHS staff and patients who contributed to today’s discovery, ”he added.
Landray is Professor of Medicine and Epidemiology in the Nuffield Department of Population Health at the University of Oxford.
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