The phase 2 trial will assess effectiveness of monoclonal antibodies in conjunction with remdesivir
WEDNESDAY, Oct. 14, 2020 (HealthDay News) — A study to assess whether certain approved or experimental drugs are effective against COVID-19 and warrant testing in large clinical trials has been launched by the U.S. National Institutes of Health (NIH).
The research will largely focus on monoclonal antibody medications. These types of drugs garnered headlines last week as President Donald Trump credited one such drug cocktail, made by Regeneron, with helping him recover from his coronavirus infection. However, the therapy is not yet approved against COVID-19 and is still considered experimental.
“The goal here is to identify as quickly as possible the experimental therapeutics that demonstrate the most clinical promise as COVID-19 treatments and move them into larger-scale testing,” said Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID).
According to the NIH, the new phase 2 adaptive, randomized, double-blind, placebo-controlled trial will enroll adults hospitalized with COVID-19 at as many as 40 U.S sites and is being conducted by the NIAID. The study will assess the approved monoclonal antibody risankizumab in conjunction with the antiviral drug remdesivir compared to a placebo plus remdesivir. It will also test the experimental monoclonal antibody lenzilumab with remdesivir compared to placebo and remdesivir. About 100 volunteers will be assigned to each study arm, with each of the study sites testing no more than three treatments at once.
The new study “aims to streamline the pathway to finding urgently needed COVID-19 treatments,” NIH Director Francis Collins, M.D., Ph.D., said in an NIH news release. That might be accomplished “by repurposing either licensed or late-stage-development medicines and testing them in a way that identifies the most promising agents for larger clinical studies in the most expedient way possible,” he said.