The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is going to start a clinical trial, and is seeking volunteers who are currently infected with SARS-CoV-2, the virus which causes COVID-19, who have mild to moderate disease not requiring hospitalization.

The Phase 2 clinical trial will evaluate the safety and efficacy of potential new therapeutics for COVID-19, including the use of antibodies to treat the disease.  The approximately 220 patients will take the experimental drug or a placebo as part of a rigorous randomized clinical trial.

If the Phase 2 portion goes well, the study will move to a Phase 3 trial with around 2,000 participants.  The study team wants to enroll patients from around the world.

The first therapeutic to be tested in this trial will be an antibody manufactured in a lab, starting with blood from a recovered COVID-19 patient, given via infusion to the volunteers.  The antibody is made by Eli Lilly and Company, headquartered in Indianapolis, Indiana,  in partnership with  AbCellera Biologics, headquartered in Vancouver, British Columbia.

COVID-19 patients often have low blood oxygen levels, so one part of the trial will be to see if the therapeutic has a positive effect on blood oxygen levels.  A goal is to see if the trial drug reduces hospitalization and deaths from COVID-19.

“Using an antibody generated by the immune system of a recovered COVID-19 patient gives us a jump start on finding a safe and effective therapeutic,” said NIAID Director Anthony S. Fauci, M.D. “Investigating a variety of different therapeutics, including monoclonal antibodies, will help ensure that we advance towards an effective treatment for people suffering from COVID-19 disease as quickly as possible.”

The effort is a public-private partnership and is also receiving support as part of the Federal Government’s “Operation Warp Speed” to quickly develop vaccines and treatments.

Click here for more on the trial.