WASHINGTON, Aug. 6 (Xinhua) -- The U.S. National Institutes of Health (NIH) announced on Thursday the start of a randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen consisting of the antiviral remdesivir plus the immunomodulator interferon beta-1a in COVID-19 patients.
The study, called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), is anticipated to enroll more than 1,000 hospitalized adults with COVID-19 at as many as 100 sites in the United States and abroad, according to a release of the NIH.
Participants must have laboratory-confirmed SARS-CoV-2 infection with evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation. People with confirmed infection who have mild symptoms or no apparent symptoms will not be included in the study, said the NIH.
They are being randomly assigned in a 1-to-1 ratio to receive either subcutaneous interferon beta-1a plus remdesivir (combination therapy) or remdesivir alone. Neither the participants nor the study team will know who is receiving which treatment regimen.
All participants will receive standard doses of remdesivir and either interferon beta-1a or a placebo. Those in the combination therapy group will receive interferon beta-1a as a 44-microgram subcutaneous injection every other day for a total of four doses during hospitalization.
Those in the remdesivir-only group will receive a matching placebo subcutaneous injection every other day for a total of four doses during hospitalization.
Investigators will evaluate whether time to recovery is shorter in the combination therapy group relative to the remdesivir-only group, said the NIH.
Recovery is defined as the participant being well enough for hospital discharge, meaning the participant either no longer requires supplemental oxygen or ongoing medical care in the hospital, or is no longer hospitalized. Recovery is evaluated up until day 29.
A key secondary goal of the study is to compare patient outcomes at day 15 using an ordinal eight-point scale ranging from fully recovered to death.
An independent data and safety monitoring board will monitor ongoing results to ensure patient well-being and safety as well as study integrity, said the NIH. Preliminary results are expected in the fall of 2020.
ACTT 3 is the third iteration of the ACTT of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. ACTT began on Feb. 21 to evaluate remdesivir, an investigational broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc.
A preliminary analysis of ACTT data found that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo.
Subcutaneous interferon beta-1a, a medication manufactured by Merck KGaA, Darmstadt, Germany, is approved in the United States and more than 90 other countries for the treatment of multiple sclerosis, according to the NIH.
In the laboratory, type 1 interferon can inhibit SARS-CoV-2 and two closely related viruses, SARS-CoV and MERS-CoV. In addition, two small randomized controlled trials suggest that treatment with interferon beta may benefit patients with COVID-19, according the NIH.
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