A clinical trial to evaluate their drug Kevzara in the treatment of patients hospitalized with a severe form of the coronavirus, has started, announced the French laboratory Sanofi and the American Regeneron, in a joint press release published on Monday.
The two companies announced that the clinical study has started in the United States and that recruitment will be launched. Regeneron will conduct the trial in the United States, while Sanofi will be responsible for future trials in the rest of the world, particularly in Italy.
Nearly 400 patients expected to be part of the clinical trial
Kevzara (sarilumab), is an immunosuppressant developed jointly by Sanofi with Regeneron, launched in 2017 to treat rheumatoid arthritis. It is a monoclonal antibody against the receptor for interleukin-6 (IL-6), a protein in the immune system that plays a role in the inflammatory process. IL-6 could play a role in the inflammatory response of the lungs of patients severely affected by Covid-19, said the two laboratories.
This trial, which will be conducted in many centers in the United States, will aim to assess the safety and efficacy of adding Kevzara to symptomatic treatments, compared to a placebo. 400 patients are expected to be recruited. The first part of the trial will assess the effect of Kevzara on patients' fever and their need for additional oxygenation.
A study already carried out on 21 patients
The second part of the trial will assess the long-term improvement, in particular in terms of mortality and reduction of hospitalization and oxygenation needs. "We think there is scientific evidence showing that Kevzara may be a potentially important treatment option for some patients," said John Reed, world research and development manager for Sanofi, quoted in the statement.
Data from a study of 21 patients in China showed that patients who received another monoclonal antibody against the interleukin-6 receptor (tocilizumab) had their fever and their need for additional oxygen reduced, recalls the communicated. At the same time, the French pharmaceutical group is working on the development of a vaccine against the new coronavirus, associated with the United States Department of Health.
Strasbourg
Coronavirus in Alsace: "In 40 years of medicine, I had never seen that," says a head of the resuscitation service in Colmar
Health
Coronavirus in Lille: The Samu du Nord does not select patients for lack of space
- Treatment
- United States
- Sanofi
- Virus
- epidemic
- Drug
- Coronavirus
- Health