The United States National Institute of Allergy and Infectious Diseases (NIAID) announced on Wednesday that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized COVID-19 adults who require supplemental oxygen.
The NIAID-sponsored trial will enroll up to 1,500 patients at approximately 100 sites in the United States and other countries.
Participants will be assigned at random to one of two treatment arms of equal size. One group will receive both dexamethasone, a corticosteroid available as a generic drug, and remdesivir, a broad-spectrum antiviral discovered and developed by American drugmaker Gilead Sciences.
The second group will receive remdesivir and baricitinib, a modulator of inflammation that is approved by the United States Food and Drug Administration to treat certain adult patients with moderate to severe rheumatoid arthritis.
FDA granted Emergency Use Authorization on Nov. 19 for baricitinib in combination with remdesivir to treat suspected or laboratory confirmed COVID-19 in hospitalized patients aged 2 years and older who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
The trial is blinded for the dexamethasone and baricitinib components, meaning investigators and participants will not know who is receiving dexamethasone and who is receiving baricitinib.
The trial will evaluate the difference in the proportion of participants surviving without requiring invasive mechanical ventilation between the two treatment arms, according to the NIAID.
A key secondary goal is to compare overall clinical status at day 15 in each group by comparing differences in the distribution of the eight-point ordinal scale in each group, said the agency.