NIAID Testing Remdesivir Plus MS Drug for COVID-19

Megan Brooks

August 12, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

A randomized controlled trial, now underway, is testing the safety and efficacy of the broad-spectrum antiviral remdesivir in combination with the immunomodulator interferon beta-1a (Rebif), a drug used for 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 trial aims to enroll more than 1000 adults hospitalized with COVID-19 at up to 100 centers in the United States and abroad.

ACTT-3 is the third iteration of ACTT. As previously reported, ACTT-1 found that for patients hospitalized with COVID-19 who received a 10-day course of remdesivir, time to recovery was significantly shorter statistically compared with those who received placebo.

The results, published in The New England Journal of Medicine, prompted the US Food and Drug Administration to issue an emergency use authorization for the drug for patients with severe COVID-19.

ACTT-3 Tests Combo Approach

Interferon beta-1a has both antiviral and anti-inflammatory properties. In a statement explaining the rationale for ACTT-3, the NIAID says type 1 interferon has been shown to inhibit SARS-CoV-2 and two closely related viruses, SARS-CoV and MERS-CoV. There is also evidence that the normal interferon response is suppressed in some people infected with SARS-CoV-2.

Furthermore, evidence from two small randomized trials suggest that treatment with interferon beta may benefit patients with COVID-19.

ACTT-3 is the first large randomized controlled trial to test the combination of interferon beta-1a and remdesivir in COVID-19 patients.

Patients eligible for ACTT-3 have laboratory-confirmed SARS-CoV-2 infection with evidence of lung involvement, including a need for supplemental oxygen; abnormal results on chest x-ray; or illness that requires mechanical ventilation. People with confirmed SARS-CoV-2 infection who have only mild symptoms or no apparent symptoms are not eligible for the study.

ACTT-3 participants are randomly assigned to receive standard doses of remdesivir (one 200-mg IV dose on day 1, followed by a 100-mg once-daily IV dose while hospitalized for up to a 10 days, which represents the total course) and either interferon beta-1a (44-μg subcutaneous injection on days 1, 3, 5, and 7 while hospitalized for a total of four doses) or matching placebo injections.

ACTT-3 trialists are evaluating whether time to recovery is shorter in the combination therapy group relative to the remdesivir-only group. Recovery is defined as being well enough for hospital discharge. Patients are being evaluated until day 29.

A key secondary goal of ACTT-3 is to compare patient outcomes at day 15 using an ordinal 8-point scale ranging from fully recovered to death. The trial also will compare other secondary outcome variables between treatment groups, including mortality alone.

Preliminary results of ACTT-3 are expected this fall. Additional information on ACTT-3 is available online.

The second iteration of ACTT, ACTT-2, which got underway on May 8, is evaluating the safety and efficacy of remdesivir plus the anti-inflammatory drug baricitinib (Olumiant) for hospitalized adults with COVID-19.

Enrollment in ACTT-2 closed on June 30 after 1034 patients were enrolled at 71 US and international centers.

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