Clinical trials investigating the efficacy of using the rheumatoid arthritis drug, Kevzara, in patients hospitalised with severe COVID-19 have now been expanded to include the EU.
The clinical programme that is being run by the pharmaceutical company Sanofi for all countries outside the US is the second trial as part of the Kevzara COVID-19 programme, which was first trialled this month in the US.
To qualify, patients must have pneumonia and be hospitalised with laboratory-confirmed COVID-19 that is classified as “severe or critical,” or be suffering from multi-organ dysfunction.
After receiving the study dose, patients will be assessed for 60 days, unless they die or are discharged before that.
The trial will be conducted in Italy, Spain, Germany, and France as well as Canada, Russia, and the US, and is expected to enroll about 300 patients.
According to a preliminary study, the drug, which is currently approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis, may be able to calm the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.
In a 21-patient cohort infected with COVID-19, patients were found to have experienced rapidly reduced fevers and 75% of them reduced their need for supplemental oxygen within days of receiving a similar medication.
“Despite this encouraging finding, it’s imperative to conduct a properly designed, randomised trial to understand the true impact of Kevzara, which we are now doing through this global clinical trial program,” said George D. Yancopoulos, co-founder, president, and chief scientific officer of Regeneron, the biotechnology company responsible for running the clinical trial in the US.
The companies are now “working with health authorities around the world to secure initiation at additional sites,” according to a press release published by Sanofi on Monday (30 March).
“Sanofi and Regeneron are relentlessly working to rapidly initiate trials around the world that will help determine whether Kevzara has the potential to play a role in addressing the COVID-19 global health crisis,” said John Reed, global head of research and development at Sanofi.
“These trials will provide important data to determine whether Kevzara ameliorates the life-threatening complications of COVID-19 infections by counteracting the overactive inflammatory responses in the lungs when damaged by the virus.”
He added he was “deeply grateful” for the daily collaboration with health authorities that are “enabling us to conduct this clinical work so quickly.”
“In addition to this clinical trial aiming to help critically ill COVID-19 patients, our work continues to bring forth a vaccine for disease prevention, along with efforts to provide other important Sanofi medicines that may help patients impacted by COVID-19.”
For the moment, the use of Kevzara to treat the symptoms of COVID-19 has not been evaluated by any regulatory authority.
As of Monday morning (30 March), worldwide cases of COVID-19 have reached 724,201 with 34,026 confirmed deaths, according to the latest figures on the Johns Hopkins University global dashboard.
[Edited by Zoran Radosavljevic]