Russia's Gamaleya Center to start clinical trials of Covid-19 monoclonal antibody drug after New Year holidays - center head

MOSCOW. Nov 11 (Interfax) - The clinical trials of a Covid-19 monoclonal antibody drug are expected to begin after the New Year holidays, Gamaleya Center head Alexander Gintsburg told Interfax.

"We are finishing the preclinical trials now and intend to shift to the clinical trials of a monoclonal medicine for Covid-19 patients after the New Year holidays," Gintsburg said.

This medicine will be used first and foremost to treat risk-group patients such as pregnant women and people suffering from obesity and diabetes "who are at high risk of contracting Covid-19," he said.

The clinical trials will help establish at which point in the disease this medicine will be most effective.

"I think that it may also be effective on the fourth or sixth day of the disease, not only at the early stages. But it will be up to the clinical trials to analyze up to what day its use will be worthwhile," Gintsburg said.

Gintsburg told Interfax on September 7, 2020, that there was a need to provide financing for a new project of the Gamaleya Center, which had registered its Covid-19 vaccine Sputnik V by that time. It is a monoclonal antibody drug for Covid-19 patients, which is able to drastically reduce the probability of fatal outcomes in Covid-19 cases. Patients with Covid-19 may receive ready antibodies as part of this therapy, in an approach that is expected to help patients' immune systems fight the infection until their own antibodies are generated.

Gintsburg said on November 11, 2020, that the Gamaleya Center had received all necessary funds and hoped to register its Covid-19 monoclonal antibody medicine in a year. Gintsburg said that the center had earlier developed a similar drug to treat the Ebola virus.

Therapy using monoclonal antibodies, or mAbs, is widely used in medicine today to treat a variety of diseases, including cancer and different inflammatory conditions.

As reported, monoclonal antibodies helped former U.S. President Donald Trump, who spent three days in a hospital in October of last year after being diagnosed with Covid-19, recover from the disease. In the United States, monoclonal antibody therapy is authorized for use in adults and children above 12 years old with mild or moderate forms of Covid-19. However, its use is forbidden for patients being treated in hospitals and for patients in need of oxygen support.