The US National Institute of Allergy and Infectious Diseases (NIAID) said Friday that it is enrolling hospitalised adults with COVID-19 in the US to take part in a study evaluating the combination of Gilead Sciences' remdesivir with Eli Lilly and Incyte's JAK inhibitor Olumiant (baricitinib) as a potential treatment. "We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalised with COVID-19," commented NIAID director Anthony Fauci, adding that the new study, dubbed ACTT 2, "will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes."
Remdesivir was recently granted emergency-use authorisation by the FDA after preliminary data from the NIAID-led ACTT trial of 1063 hospitalised patients with advanced COVID-19 showed the antiviral medicine cut recovery times by 31% versus placebo. Gilead's drug was also associated with a mortality rate of 8%, compared to 11.6% for placebo, although Fauci said at the time that the mortality benefit had "not yet reached statistical significance."
The ACTT 2 trial is expected to enrol more than 1000 participants with laboratory-confirmed SARS-CoV-2 infection, as well as evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation. Patients who are asymptomatic or who have mild symptoms will be excluded from the trial. Participants will be randomised to receive either oral Olumiant or placebo, on top of intravenous remdesivir.
Investigators will evaluate whether time to recovery, up until day 29, is shorter in the combination arm relative to remdesivir alone, with recovery defined as the patient either no longer needing supplemental oxygen or ongoing medical care in the hospital, or no longer requiring hospitalisation. A key secondary goal will compare patient outcomes at day 15 using an ordinal eight-point scale ranging from fully recovered to death. The trial will also look at other secondary outcomes between the two treatment groups, including mortality alone.
Olumiant is already approved in the US and several other countries as a treatment for adults with moderately to severely active rheumatoid arthritis. The NIAID noted that some patients with COVID-19 experience acute respiratory distress syndrome, and that the potential benefit of Olumiant, which inhibits cytokine signaling, "has been described in a case series of critically ill patients who recovered from COVID-19."
Other drugs previously approved by the FDA to treat rheumatoid arthritis have also been proposed as possible COVID-19 treatments, including Roche's Actemra (tocilizumab) and Sanofi and Regeneron Pharmaceuticals' Kevzara (sarilumab).
For related analysis, see ViewPoints: Remdesivir reality sinks in for Gilead. See also ViewPoints: Something is better than nothing – the remdesivir story.
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