Editor’s Note: Find the latest COVID-19 news and guidance from Medscape Coronavirus Resource Center..
In an ongoing randomized controlled trial, the broad-spectrum antiviral drug lemdecivir and the immunomodulator interferon beta 1a (Rebif), Multiple sclerosis, For patients with COVID-19.
The Adaptive COVID-19 Treatment Trial 3 (ACTT-3) is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The purpose of this study is to enroll more than 1000 adults in up to 100 centers in the United States and abroad who are hospitalized for COVID-19.
ACTT-3 is the third iteration of ACTT. So Previously reportedACTT-1 was found to be statistically significantly shorter in time to recovery in patients admitted with COVID-19 who received a 10-day course of lemdecibir than in patients who received placebo.
Results announced New England Medical Journal, Urged US Food and Drug Administration To publish Emergency use permit for the drug for patients with severe COVID-19.
ACTT-3 test combo approach
Interferon beta 1a has both antiviral and anti-inflammatory properties. In a statement explaining the rationale for ACTT-3, NIAID states that type 1 interferon has been shown to inhibit SARS-CoV-2 and two closely related viruses, SARS-CoV and MERS-CoV. I am. There is also evidence that the normal interferon response is suppressed in some people infected with SARS-CoV-2.
In addition, evidence from two small randomized trials suggests that treatment with interferon beta may benefit COVID-19 patients.
ACTT-3 is the first large randomized controlled trial to test the combination of interferon beta 1a and lemdecibir in COVID-19 patients.
Patients eligible for ACTT-3 have a laboratory-confirmed SARS-CoV-2 infection and have evidence of lung involvement, including the need for supplemental oxygen. Abnormal chest x-ray results; or required illness Mechanical ventilation.. Persons with confirmed SARS-CoV-2 infection who have only mild symptoms or no obvious symptoms are not eligible for the study.
ACTT-3 participants received a standard dose of lemdecivir (200 mg IV once on day 1 followed by 100 mg IV IV for up to 10 days, representing the entire course) Will be randomly assigned to receive. And interferon beta-1a (44-μg subcutaneous injection on day 1, 3, 5, and 7 during a total of 4 hospital stays) or a matching placebo injection.
The ACTT-3 trial investigators are evaluating whether the combination therapy group has a faster time to recovery than the lemdecibir-only group. Recovery is defined as sufficient for discharge. Patients are evaluated until Day 29.
ACTT-3’s primary secondary goal is to compare patient outcomes on Day 15 using a standard 8-point scale ranging from complete recovery to death. The trial also compares other secondary outcome variables between treatment groups, including mortality only.
Preliminary results for ACTT-3 are expected this fall. Additional information on ACTT-3 Available online..
The second iteration of ACTT, ACTT-2Started on May 8 and assesses the safety and efficacy of lemdecivir and anti-inflammatory drugs Ballicitinib (Olumiant) An adult hospitalized for COVID-19.
Enrollment in ACTT-2 ended 30 June after 1034 patients were enrolled in 71 US and international centers.
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