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Vanderbilt investigators encouraged by early results of placebo-controlled remdesivir trial

Apr. 29, 2020, 1:54 PM

 

by Craig Boerner

A preliminary look at data from hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) in a randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir is showing promising results.

The international trial, which includes investigators from Vanderbilt University Medical Center, is showing that patients who received remdesivir are recovering an average of four days faster (11 days vs. 15 days) than patients who were given placebo.

Likewise, mortality rates for patients who received the drug are 8% as compared to 11.6% of the placebo group.

It is only a preliminary look at the data, and additional data are expected to be available in the upcoming weeks.

“Remdesivir has been evaluated in laboratory studies at Vanderbilt for many years now,” said Vanderbilt’s Vaccine and Treatment Evaluation Unit (VTEU) principal investigator C. Buddy Creech, MD, MPH, associate professor of Pediatrics and director of the Vanderbilt Vaccine Research Program (VVRP).

“This is a very large, carefully designed trial with over 1,000 patients enrolled in the U.S. and around the world. Patients were given the drug at various stages of their illness and with various levels of severity; it is definitely encouraging that we can see faster recovery even with this first look at the data.”

Coronaviruses are a large family of viruses that typically cause mild to moderate upper respiratory illnesses like the common cold. New coronaviruses, such as the ones that cause MERS, SARS and COVID-19, have emerged during the last two decades and have shown the ability to cause severe disease in people.

The Adaptive COVID-19 Treatment Trial (ACTT) is a multicenter trial conducted at 68 sites — 47 in the U.S. and 21 in countries in Europe and Asia — to test various treatments for COVID-19. In the first stage of ACTT, remdesivir is being compared to placebo in adult patients hospitalized with moderate to severe COVID-19. Remdesivir has been previously tested as a treatment for patients with Ebola virus disease. It has also been studied in animals as a treatment for SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome), both of which are caused by coronaviruses.

Patients enrolled in the study received either placebo or 200 mg of remdesivir administered intravenously on day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to 10 days.

ACTT, sponsored by the NIH’s National Institute of Allergy and Infectious Diseases, is the first clinical trial in the United States to evaluate a treatment for COVID-19 and began in February. The first participant was an American who had been quarantined on the Diamond Princess cruise ship that was docked in Yokohama, Japan.

The VVRP recently received a NIH Grant as a VTEU. The VTEU is part of the Infectious Diseases Clinical Research Consortium (IDCRC); the IDCRC and VTEUs contribute to federal efforts to bolster infectious diseases clinical trial research with the capacity to respond to emerging diseases.

The ACTT is funded by Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Vanderbilt Vaccine and Treatment Evaluation Unit, Grant Numbers 1-UM1-AI148452-01 and 3-UM1-AI148452-01S1.

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