Three pharma companies launched the first human clinical trials of experimental COVID-19 treatments this week.
One trial is for a vaccine developed by Moderna and the National Institutes of Health (NIH). The phase one trial is taking place in the Seattle area and has been funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
This first trial will enroll about 45 participants and will evaluate three different doses of the vaccine and the patient’s immune response, according to the NIH. The patients will be given the vaccine in the upper arm and receive two doses about 28 days apart. Patients will continue to be monitored for a year after the doses and the trial will enroll patients over the next six weeks.
The Moderna and NIH vaccine uses messenger RNA (mRNA) that “directs the body’s cells to express a virus protein that it is hoped will elicit a robust immune response,” according to the NIH. The vaccine was able to go to trials so quickly because Moderna was already working with researchers at NIAID’s Vaccine Research Center on a vaccine for SARS and MERS, other members of the coronavirus family.
The second trial is for a treatment for hospitalized COVID-19 patients developed by Sanofi and Regeneron.
That trial is evaluating rheumatoid arthritis treatment Kevzara in patients with COVID-19. The drug may slow the overactive inflammatory response in the lungs caused by the virus, according to the companies. This double-blind trial will begin at medical centers in New York and will compare Kevzara plus supportive care to only supportive care and to a placebo.
The trial is expected to enroll up to 400 participants across 16 sites. It will measure the drug’s effect on fever and the need for supplemental oxygen in patients with severe and critical cases of COVID-19. A second part of the trial will look at longer-term outcomes like preventing death and reducing the need for mechanical ventilation, supplemental oxygen and hospitalization.
Researchers believe Kevzara’s ability to inhibit the interleukin-6 (IL-6) pathway will help treat these patients. A separate trial in China testing the same IL-6 pathway in 21 patients found that they experienced rapidly reduced fevers and 75% reduced their need for supplemental oxygen within days of receiving another IL-6 receptor antibody.
All three pharma companies credited their work with federal agencies to the rapid development and quick start to human trials for these experimental treatments. Shortly after the COVID-19 outbreak began, the Food and Drug Administration said it would take steps to expedite any coronavirus vaccine through the drug approval process using pathways like the Emergency Use Authorization.