NIAID Launching RCT of Rebif-Remdesivir Combination as Treatment for COVID-19

August 7, 2020

Double-blind study will compare Rebif-remdesivir combination with remdesivir-alone in hospitalized COVID-19 patients

The National Institute of Allergy and Infectious Diseases (NIAID) is conducting a 1,000-patient randomized clinical trial to test whether the pairing of Rebif (interferon beta-1a), an multiple sclerosis drug, with remdesivir, the antiviral drug, might be an effective treatment for COVID-19.

The Adaptive COVID-19 Treatment Trial 3 (ACTT 3) participants are being randomly assigned in a 1-to-1 ratio to receive either subcutaneous interferon beta-1a with remdesivir or remdesivir alone, NIAID said in a press release issued earlier this week.

Subcutaneous interferon beta-1a is manufactured by Merck KGaA, D Germany, is approved in the U.S. and more than 90 other countries for the treatment of multiple sclerosis. The drug is marketed under the brand name Rebif by EMD Serono, the North American biopharmaceutical business of Merck KGaA.

Researchers are testing interferon beta-1a partly because it has the same amino acid sequence as a protein called interferon beta, and interferon beta is a member of class of type 1 interferons that infected cells naturally produce to help mount an immune response against pathogens, especially viruses, according to NIAID.

Lab experiments have shown that type 1 interferon has some inhibitory effects on SARS-CoV-2, the virus that causes COVID-19, and two closely related coronaviruses, SARS-CoV, the coronavirus that causes Severe Acute Respiratory Syndrome (SARS) and MERS-CoV, the coronavirus that causes Middle East Respiratory Syndrome (MERS).

The press release also mentions that the results of two, small randomized controlled trials suggest that treatment with interferon beta may benefit patients with COVID-19. However, the combination of interferon beta-1a and remdesivir for treating COVID-19 has not been evaluated in a large, randomized controlled trial, thus ACTT 3.

In the study those randomized to combination therapy will receive interferon beta-1a as a 44-mcg subcutaneous injection every other day and a total of four doses during hospitalization, according to the NIAID press release. Those in the remdesivir-alone group will receive a matching placebo subcutaneous injection every other day and a total of four doses during hospitalization. The study is double blinded: Neither the patients nor the clinicians conducting the trial will know who is getting interferon beta-1a and who is getting the placebo injections.

Subcutaneous interferon beta-1a is manufactured by Merck KGaA, D Germany, is approved in the U.S. and more than 90 other countries for the treatment of multiple sclerosis. The drug is marketed under the brand name Rebif by EMD Serono, the North American biopharmaceutical business of Merck KGaA.