An unspecified number of patients admitted to four Massachusetts hospitals with severe COVID-19 are receiving an approved rheumatoid arthritis drug to determine whether it can be used to treat one of the most dangerous complications of the disease, acute respiratory distress syndrome.
The drug, Kevzara, is being studied for its potential ability to suppress the overactive inflammatory immune response in patients’ lungs that can lead to death. Preliminary results of the mid-stage clinical trial are expected by the end of April, said Bill Sibold, head of Cambridge-based Sanofi Genzyme. Its French parent company, Sanofi, developed the drug with Regeneron Pharmaceuticals of New York.
Massachusetts General Hospital, Brigham and Women’s Hospital, Tufts Medical Center, and Beth Israel Deaconess Medical Center are among 64 hospitals at 51 US sites where the drug is being tested. All told, about 1,000 patients are participating in the study. Sibold couldn’t specify how many of them are in Massachusetts.
Patients began receiving doses the week of March 16. Sibold said it’s way too soon to discuss whether the drug is helping them.
“We have to see the data," he said. “I’m hopeful in the sense that we need more solutions for COVID-19, and if this can have a positive effect on patients, that’s a wonderful thing.”
The primary goal of the clinical trial is to determine if Kevzara lowers fever and then curbs the need for supplemental oxygen to help patients breathe, according to a Sanofi spokeswoman.
Scientists around the world are studying at least 95 potential treatments for the coronavirus in laboratories and hospitals, according to an online tracker by the Milken Institute, a nonprofit think tank in Santa Monica, Calif. The possible treatments include several decades-old medicines approved for diseases ranging from HIV to influenza.
Kevzara was developed by Sanofi and Regeneron and approved in 2017 to treat rheumatoid arthritis, an autoimmune disorder that causes the body’s immune system to mistakenly attack tissues. Researchers believe it might be useful because many patients who become critically ill with COVID-19 experience a “cytokine storm,” a runaway response in which the immune system attacks the body’s organs. Some researchers believe drugs that suppress the immune system, including monoclonal antibodies such as Kevzara, might counter that.
“It’s a really promising approach,” said Dr. Kathryn Stephenson, an assistant professor of medicine at Harvard Medical School and co-investigator in the study of Kevzara at Beth Israel. “We know that there’s a really prominent piece of this disease process that has to do with a huge rise in inflammation. At the point where patients are getting really sick, it looks like we’re going to need some intervention to turn down the immune response.”
A recent study in China of 21 COVID-19 patients with acute respiratory distress found that Actemra, a similar rheumatoid arthritis medicine made by Swiss drug giant Roche, helped suppress that overreaction. The study, which wasn’t peer-reviewed, found that fevers in patients who received Actemra fell rapidly and that within a matter of days, most didn’t need supplemental oxygen. Roche is now running a clinical trial of that medicine in coronavirus patients, with research sites that include Boston.
Regeneron is overseeing the clinical trial of Kevzara in the United States. Sanofi, whose roughly 4,800 employees at Sanofi Genzyme make up one of the largest workforces of any drug maker in Massachusetts, is overseeing testing of Kevzara on patients in Italy, Spain, Germany, France, Canada, and Russia.
Sanofi is also launching two clinical trials of hydroxychloroquine, an old malaria drug that it sells outside the United States under the brand name Plaquenil. The medicine has been in use since the 1950s. Sanofi began making as much of it as it could in February after Chinese data indicated the medicine could help some patients with coronavirus.
One of the trials ― including about 210 patients ― will take place in the United States, France, and the Netherlands and will test the malaria drug on coronavirus outpatients during the early stage of the disease.
The second hydroxychloroquine trial will take place in France, Germany, the United Kingdom, Denmark, and the Czech Republic. It will focus on people hospitalized with moderate and severe cases of the disease, and will include about 300 patients.
President Trump has aggressively promoted the malaria drug as a treatment for COVID-19, although experts have warned that it has yet to be proved safe or effective for coronavirus.
Sanofi is also working on two potential vaccines to prevent coronavirus. One is a collaboration with Lexington-based Translate Bio and seeks to develop a new messenger RNA vaccine. The other is a collaboration with the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services, and relies on recombinant DNA.
The World Health Organization lists more than 40 potential vaccines in development globally.
Jonathan Saltzman can be reached at firstname.lastname@example.org