NIH – randomized controlled trial
As reported on Thursday, August 6, 2020, the National Institutes of Health (NIH), Bethesda, MD – one of the world’s foremost medical research agencies – has begun the first large randomized controlled trial of the combination of interferon beta-1a and remdesivir for treating COVID-19.
This clinical trial evaluating the safety and efficacy of the antiviral remdesivir plus interferon beta-1a is anticipated to enroll more than 1,000 hospitalized adults with COVID-19 at nearly 100 sites in the United States and abroad.
Interferon beta-1a, a medication manufactured by Merck KGaA, Darmstadt, Germany, is approved in the U.S. and more than 90 other countries for the treatment of multiple sclerosis. Interferon beta-1a has the same amino acid sequence as a naturally occurring protein interferon beta, which is part of the type 1 interferons.
The rationale behind the combination of interferon beta-1a and remdesivir
Remdesivir has been shown to speed up the recovery of coronavirus patients and is the first antiviral treatment with proven efficacy against SARS-CoV-2 in an animal model of COVID-19. In the United States, remdesivir is authorized for use under an Emergency Use Authorization (EUA) only for the treatment of severe COVID-19. In the European Union, the European Commission has recently authorized the use of remdesivir to treat severe cases of COVID-19. Remdesivir has been also approved as a treatment for patients with severe COVID-19 in Japan, Taiwan, India, Singapore and the United Arab Emirates.
In 1957, the Scottish virologist Alick Isaacs and the Swiss researcher Jean-Jacques Lindemann, at the National Institute for Medical Research in London, isolated and discovered the first cytokine – interferon. They found that cells in laboratory cultures when infected by a virus secreted a substance that protects other cells from infection. The term ‘interferon’ was coined, and today that specific interfering agent is known as a ‘Type I interferon’.
It has been reported that patients with COVID-19 have impaired type I interferon activity, where the type-I IFN deficiency is a hallmark of severe COVID-19. Also, SARS-CoV-2 infection drives a lower antiviral transcriptional response that is marked by low IFN-I and IFN-III levels.
On July 20 this year, the UK company Synairgen reported unpublished data from a Phase 2 trial of an experimental IFN drug, nebulized IFN-beta. In this trial, involving 101 patients from 9 specialized sites in the UK, the SNG001, the Synairgen company’s wholly-owned inhaled formulation of interferon beta, appeared to reduce the risk of hospitalized COVID-19 patients developing severe disease by 79 percent.
Coming back to the above mentioned NIH’s randomized, controlled clinical trial – ACTT 3 is the third iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT). ACTT began on Feb. 21 to evaluate remdesivir, a broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc, of Foster City, California. As per the NIH’s News Release, the combination of interferon beta-1a and remdesivir for treating COVID-19 has not been evaluated in a large, randomized controlled trial.
Read more: NIH’s News Release
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Cover Image Credit: Colorized scanning electron micrograph of a cell heavily infected with SARS-CoV-2 virus particles (yellow), isolated from a patient sample. The black area in the image is extracellular space between the cells. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. NIAID.