Interferon adds no clinical benefit for hospitalized patients with COVID-19
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Combining the immunomodulator interferon beta-1a with remdesivir did not improve treatment among hospitalized adults with COVID-19 compared with remdesivir alone, data from a clinical trial showed.
Andre C. Kalil, MD, MPH, director of transplant infectious diseases at the University of Nebraska Medical Center, and colleagues conducted a double-blind, randomized, placebo-controlled trial among adults with COVID-19 at 63 hospitals in Japan, Mexico, Singapore, South Korea and the United States.
Participants were eligible for inclusion if they met criteria suggestive of a lower respiratory tract infection, such as the presence of radiographic infiltrates on imaging, a peripheral oxygen saturation on room air of 94% or less, or requiring supplemental oxygen.
The researchers randomly assigned patients in a 1:1 ratio to receive IV remdesivir — a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose daily for up to 9 days — and up to four 44 µg doses of interferon beta-1a or placebo administered subcutaneously every other day.
From Aug. 5 through Nov. 11, 2020, the researchers enrolled 969 patients: 487 in the interferon group and 482 in the placebo arm. They evaluated patients daily from days 1 to 29. If a patient was discharged, they were contacted on days 15, 22 and 29.
The recovery time for patients in both the interferon and placebo groups was 5 days (the researchers were unable to estimate a 95% CI). Additionally, 21 of 487 (4%) patients in the interferon group died, compared with 16 of 482 (3%) in the placebo group. Death among patients with an ordinal score of 6 at baseline occurred in seven out of 35 (20%) patients in the interferon group and four out of 34 (12%) patients in the placebo group.
Among patients with an ordinal score of 4 or 5 at baseline, grade 3 or 4 adverse events were reported in 172 of 442 patients (39%) in the interferon group and in 138 of 435 (32%) patients who received placebo. The most common grade 3 or 4 adverse event was a decreased lymphocyte count, which occurred in 5% of all patients.
“Even though no efficacy or clinically significant differences in safety were observed between the interferon beta-1a plus remdesivir and placebo plus remdesivir groups overall, patients requiring high-flow supplemental oxygen or non-invasive ventilation at baseline who received interferon beta-1a appeared to have worse outcomes and more serious adverse events, particularly worsening of respiratory status, than those who received placebo,” the authors wrote.
References:
Clinical Trials. Adaptive COVID-19 Treatment Trial 3 (ACTT-3). https://clinicaltrials.gov/ct2/show/study/NCT04492475. Accessed Oct. 19, 2021.
Kalil AC, et al. Lancet Respir Med. 2021;doi:10.1016/S2213-2600(21)00384-2.
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