A clinical trial involving COVID-19 patients hospitalized at UT Health San Antonio and University Health, among roughly 100 sites globally, found that a combination of the drugs baricitinib and remdesivir reduced time to recovery, according to results published Dec. 11 in the New England Journal of Medicine.
Six researchers from UT Health San Antonio and University Health are coauthors of the publication because of the San Antonio site's sizable patient enrollment in the trial.
WHAT'S THE IMPACT?
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The Adaptive COVID-19 Treatment Trial 2, which compared the combination therapy versus remdesivir paired with an inactive placebo in hospitalized COVID-19 patients, was supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Significantly, patients on high oxygen by nasal canula or receiving breathing assistance with a mask when they were enrolled in the study had a time to recovery of 10 days with combination treatment versus 18 days with remdesivir and placebo.
Investigators also saw a difference in patient survival. The 28-day death rate was 5.1% in the combination therapy group and 7.8% in the remdesivir placebo group.
Remdesivir is a direct-acting antiviral drug, whereas baricitinib is an anti-inflammatory medicine. The former markedly improved recovery of critically ill patients in the first round of the study, and the latter further helped patients in the second round.
Investigators said the combination is so effective in part because baricitinib has activity against the coronavirus – unlike other anti-inflammatory drugs – while also being an effective inhibitor of the inflammation caused by the virus.
THE LARGER TREND
Baricitinib is approved for the treatment of patients with active rheumatoid arthritis. The U.S. Food and Drug Administration issued an emergency use authorization on Nov. 19, 2020, for baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.
In October, the FDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years old and older and weighing at least 88 pounds for COVID-19 treatments requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care, the FDA said. Veklury was the first coronavirus treatment to receive FDA approval.
In November, the FDA granted emergency use authorization for Eli Lilly and Company's investigational neutralizing antibody bamlanivimab. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalization.