An Antiviral drug shows benefit: Story behind the story

Most of us watched the news of Dr. Anthony Fauci on April 29, 2020 announcing positive results of the clinical trial of the antiviral drug remdesivir. This positive news was like a ray of bright sunshine suddenly peeking through the dark clouds that had hung over the nation for last two months. It looks like that we have a winner.

As good a news as this is, it is still preliminary and not the magic bullet that we are hoping for. So, I spent hours this morning digging through the sources and here is the story behind the story.

The Story:

The National Institute of Allergy and Infectious Diseases (NIAID, a division of the NIH, USA) sponsored clinical trial shows remdesivir accelerates recovery from advanced COVID-19. The NIH News Release April 29. 2020. 

Story behind the story:

The NIAID had launched a multicenter clinical trial of the drug remdesivir in February 2020 in 100 testing sites globally. The drug, given intravenously, was to be tested in hospitalized patients with confirmed COVID-19 illness. All of the patients had severe pneumonia. The trial was designed to be double-blind and randomized (i.e. neither the patients nor the doctors knew if the patient was getting the real drug or the placebo). The outcomes of research drug group were to be compared with that of the placebo-receiving group. Even though the initial plan was to have at least 286 patients in each of the two groups, the trial had accrued 1,063 patients as of 4/27/2020.

As it is in many such clinical trials, an interim data analysis was conducted by an independent data and safety monitoring board (DSMB) appointed to oversee the clinical trial. The board met on April 27 and reported the following results: The drug remdesivir was 31% faster than placebo to achieve recovery from pneumonia. Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.

This clinical trial (named ACTT) is registered as clinical trial Identifier: NCT04280705. The trial is ongoing and is still recruiting patients as of 4/27/2020.  Based on the preliminary findings and ethical reasons, the trial has been modified by removing the placebo arm. From now on, everyone enrolled in the trial will receive the drug remdesivir.

  

Conclusion:

The news that we have identified an effective drug that reduces the intensity of pneumonia and the hospital stay and potentially reduces the mortality, is something to cheer about. We must recognize however, that this is based on preliminary and interim findings. As the report states, remdesivir is not a cure. It has the potential to increase the chances of survival. The toxicity of the drug in those who have or don’t have any underlying diseases, will hopefully be forthcoming in the near future. Currently the treatment is free for those who are enrolled in the clinical trial.

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) on 5/1/2020 for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.The issuance of an EUA is different than FDA approval. In determining whether to issue an EUA, the FDA evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency.

The clinical trial will continue and the data will continue to be provided to the FDA. Remdesivir is the generic name. The brand name has yet not be selected.  Similarly, the price of each vial or one course of treatment is also not known at this time.

Actual photo of a newly born 4 coronaviruses emerging from a cell. This image was taken by transmission electron microscope.

Credit: NIAID-RML