A clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) in the US has launched to assess remdesivir plus baricitinib for the treatment of Covid-19.
Gilead Sciences‘ remdesivir is an experimental antiviral drug that received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to treat Covid-19.
Meanwhile, Eli Lilly’s baricitinib (Olumiant) is an anti-inflammatory drug indicated to treat adults with moderately to severely active rheumatoid arthritis.
In some patients, Covid-19 causes acute respiratory distress syndrome (ARDS), which is characterised by inflammation of the lungs resulting in shortness of breath and rapid breathing.
Oral administration of baricitinib is said to inhibit cytokine signaling that is associated with inflammatory responses.
The new NIAID trial, named ACTT2, follows the ACTT study that assessed remdesivir alone in Covid-19 patients. ACTT enrolled 1,063 subjects at 47 US and 21 international sites.
Preliminary data showed a 31% faster time to recovery in patients treated with Gilead’s drug versus placebo. The median time to recovery was 11 days versus 15 days, respectively.
NIAID director Anthony Fauci said: “We now have solid data showing that remdesivir diminishes to a modest degree the time to recovery for people hospitalised with Covid-19.
“ACTT 2 will examine if adding an anti-inflammatory agent to the remdesivir regimen can provide additional benefit for patients, including improving mortality outcomes.”
ACTT2 is designed to recruit approximately 1,000 hospitalised patients at around 100 US and international sites. Participants in the randomised, controlled, double-blind study will receive remdesivir alone or remdesivir plus baricitinib.
Remdesivir will be given as one 200mg IV dose followed by a 100mg once-daily IV dose up to a ten-day treatment course during hospitalisation. Baricitinib will be given as a 4mg oral dose for the duration of hospitalisation up to a 14-day total treatment course.
The main objective of the trial is to compare time to recovery between remdesivir alone and remdesivir plus baricitinib arms. A key secondary outcome is patient outcomes at day 15.