US NIH launches clinical trial to test potential therapeutics for mild, moderate COVID-19

WASHINGTON -- The US National Institutes of Health (NIH) said on Tuesday a Phase 2 clinical trial will evaluate the safety and efficacy of potential new therapeutics for COVID-19, including an investigational therapeutic based on synthetic monoclonal antibodies (mAbs) to treat the disease.

Researchers sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, are working with clinical sites to identify potential patient volunteers currently infected with SARS-CoV-2, the virus which causes COVID-19, who have mild to moderate disease not requiring hospitalization, according to a release of NIH.

They will be invited to take an experimental therapy or a placebo as part of a rigorously designed randomized clinical trial. The trial, which is known as ACTIV-2, also may investigate other experimental therapeutics later under the same trial protocol.

The design of the study is adaptive to enable maximum flexibility in the shortest time frame. If the experimental treatment appears effective in the first stage, the treatment can be advanced rapidly to testing in larger groups of volunteers. The study also can be adapted to test additional therapeutics, according to NIH.

"We have seen encouraging, rapid results from other adaptive treatment trials for COVID-19," said NIH Director Francis Collins. "Under ACTIV, specific therapeutics are being prioritized based on their likelihood for success. Prioritized therapeutics under ACTIV will use a master protocol that emphasizes flexibility, which enables these critical trials to be conducted without incurring delays when a treatment shows promise."

The first therapeutic to be tested in this trial will be LY-CoV555, an investigational monoclonal antibody made by Eli Lilly and Company.

This antibody, which was discovered by AbCellera in collaboration with NIAID's Vaccine Research Center, was isolated from a blood sample from a recovered COVID-19 patient. Copies of this antibody were then synthesized in a lab -- the term "monoclonal" refers to these laboratory-manufactured antibodies.

"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," said NIAID Director Anthony Fauci.