A phase 3 trial evaluating the efficacy and safety of remdesivir, an investigational broad spectrum antiviral, in combination with interferon beta-1a, for the treatment of coronavirus disease 2019 (COVID-19) has begun.
The multicenter, adaptive, double-blind, placebo-controlled ACTT 3 (Adaptive COVID-19 Treatment Trial 3) study will enroll more than 1000 hospitalized adult patients with COVID-19 at approximately 100 sites globally. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Eligible patients must have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with evidence of lung involvement, including a need for supplemental oxygen, abnormal chest X-rays, or illness requiring mechanical ventilation. Patients will be randomized 1:1 to receive either remdesivir plus 44mcg of subcutaneous interferon beta-1a every other day for a total of 4 doses, or remdesivir alone. Interferon beta-1a is currently approved by the Food and Drug Administration for the treatment of multiple sclerosis; it has been shown to have both antiviral and anti-inflammatory properties.
The primary end point of the study is the time to recovery, defined as either being discharged from the hospital (with or without some limitation on activities) or being well enough for hospital discharge (no longer requiring either supplemental oxygen or ongoing medical care in the hospital), through day 29. A key secondary end point will compare patient outcomes at day 15 using an ordinal 8-point scale ranging from fully recovered to death.
Preliminary results are expected in the fall of 2020. An independent Data and Safety Monitoring Board (DSMB) will review data to make recommendations regarding early study closure or changes to study arms.
For more information visit nih.gov.
1. NIH clinical trial testing remdesivir plus interferon beta-1a for COVID-19 treatment begins. https://www.niaid.nih.gov/news-events/nih-clinical-trial-testing-remdesivir-plus-interferon-beta-1a-covid-19-treatment-begins. Accessed August 6, 2020.