Adaptive COVID-19 Treatment Trial of New Drug Combination Enters Next Stage

The Adaptive COVID-19 Treatment Trial (ACTT), to evaluate treatment options for people hospitalized with severe COVID-19 infection, has entered the next stage and will now study remdesivir in combination with baricitinib or placebo.

The new iteration of the trial, known as ACTT 2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is being conducted by Montefiore Health System (New York, NY, USA) and Albert Einstein College of Medicine (New York, NY, USA).

Following up on the promising results of Gilead’s broad-spectrum antiviral drug remdesivir, the trial is now studying remdesivir in combination with baricitinib or placebo in a double-blind, randomized trial. Baricitinib is marketed for reducing inflammation associated with rheumatoid arthritis. Researchers want to know if baricitinib combined with remdesivir can prevent or reduce the hyper-inflammatory "cytokine storm" that can fatally overwhelm the lungs and other parts of the body in people with COVID-19 when their immune system reacts to coronavirus infection.

Patients enrolled in ACTT 2 are hospitalized with a laboratory-confirmed coronavirus infection and lung complications, including rattling sounds when breathing, a need for supplemental oxygen, abnormal chest X-rays showing pneumonia, or the need for a mechanical ventilator. All patients will receive remdesivir intravenously for up to 10 days. Half of the patients will also be given baricitinib by mouth, with the remaining half receiving an identical placebo, both for up to 14 days.

"What concerns us is that in some people the immune response to coronavirus can be more deadly than the infection itself, and there is no known treatment for this yet," said Barry Zingman, M.D., professor of medicine at Einstein and clinical director, infectious diseases, at the Moses division of Montefiore Health System. "Including baricitinib in our trial may reduce COVID-19-related inflammation and combining baricitinib with remdesivir may yield an even more effective treatment option for people most severely affected by this illness."

Related Links:
Montefiore Health System
Albert Einstein College of Medicine