A treatment regimen that includes the investigational antiviral remdesivir plus the Janus kinase inhibitor baricitinib is being evaluated in hospitalized adults with coronavirus disease 2019 (COVID) in a clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The ACTT 2 study, which is expected to enroll over 1000 patients across approximately 100 US and international sites, is assessing the combination therapy vs remdesivir monotherapy in patients with confirmed SARS-CoV-2 infection who have either a need for supplemental oxygen, abnormal chest X-ray, or illness requiring mechanical ventilation.
Patients will be randomized to receive oral baricitinib (for up to 14 days of treatment) plus intravenous (IV) remdesivir (for up to 10 days of treatment) or placebo plus IV remdesivir; if necessary, baricitinib will be crushed and given through a nasogastric tube.
The primary end point of the study is time to recovery, defined as a patient no longer requiring supplemental oxygen or ongoing medical care in the hospital; patient outcomes at day 15 will also be evaluated as a key secondary outcome measure using an ordinal 8-point scale ranging from fully recovered to death.
“We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalized with COVID-19,” said NIAID Director Anthony S. Fauci, MD “ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”
Baricitinib is currently marketed under the brand name Olumiant for the treatment of rheumatoid arthritis. There has been evidence suggesting that regulating overactive signaling through the JAK-STAT pathway during a cytokine storm could be a potential treatment approach for COVID-19 patients.
For more information visit nih.gov.