A randomized, controlled, double-blind clinical trial evaluating the safety and efficacy of a treatment regimen of investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for COVID-19 has begun.
The trial is expected to start at about 100 US and international sites and more than 1,000 patients are expected to be enrolled.
It is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) which is a part of National Institutes of Health (NIH). This clinical trial is 2nd part of NIAID’s Adaptive Covid-19 Treatment Trial (ACTT).
Remdesivir, an investigational antiviral drug developed by Gilead Sciences is approved for emergency use in COVID-19 by FDA.
Baricitinib- a product licensed to Eli Lilly and Company by Incyte and is available under brand name Olumiant is approved for treating acute rheumatoid arthritis. Baricitinib, when taken orally inhibit cytokine signaling which cause inflammatory responses.
Patients will be divided into two arms. Arm 1 participants will receive oral baricitinib and IV remdesivir. Arm 2 participants will receive oral placebo tablet and IV remdesivir. Baricitinib is administered as 400 mg oral dose or through nasogastric tube if required, up to 14 days total course of treatment. The dose of remdesivir is one 200 mg IV dose followed by 100 mg once daily IV dose up to 10 days total course of treatment.
The recovery time in the Arm 1 and Arm 2 will be evaluated. Recovery is defined as participant being well enough for hospital discharge or is no longer hospitalized. Other secondary outcomes including mortality will also be compared.
Bikash is a biologist with background in cell biology, molecular biology, immunology and microbiology. He works as an Analytical Chemist III for a CRO company called Avomeen in Ann Arbor, Michigan, US. He established biologics lab there. He loves to help other companies to solve their problems.
