NIH Launches Clinical Trial for Potential Coronavirus Vaccine

February 26, 2020 - The National Institute of Health (NIH) is sponsoring the first controlled clinical trial in the US at the University of Nebraska Medical Center (UNMC) to evaluate a possible coronavirus (COVID-19) vaccine, according to a new press release.

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The trial regulatory sponsor is the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH).  The trial will uncover the safety and efficacy of the antiviral remdesivir in adults affected with COVID-19.  

“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said NIAID Director and US Coronavirus Task Force member Anthony S. Fauci, MD. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”

Remdesivir, an investigational broad-spectrum antiviral treatment, was developed by Gilead Sciences Inc to treat Ebola back in 2013 but is a promising treatment for COVID-19. 

“Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19,” Gilead emphasized in a recent article. 

The coronavirus is caused by the SARS-CoV-2 virus. As of February 24, the World Health Organization (WHO) reported 77,262 confirmed cases of COVID-19, with 14 of those cases being found in the US. An additional 39 cases were among individuals repatriated to the US, according to the CDC. 

The trial leader will be Andre Kalil, MD, professor of internal medicine at UNMC and an infectious disease physician at Nebraska Medicine. The first US trial participant is an American who volunteered after being quarantined on the cruise ship that docked in Yokohama, Japan earlier this month.

The study can be adapted to evaluate additional investigative treatments and researchers hope to eventually enroll participants at other sites in the US and worldwide. 

Participants in the sponsored trial must have a confirmed case of the SARS CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing with a need for additional oxygen or abnormal chest x-rays, or illness requiring mechanical ventilation, the press release stated. 

Individuals who have mild, cold-like symptoms or no symptoms at all are not eligible to participate in the trial. 

After participants receive a baseline physical exam, they will be randomly assigned to either the remdesivir or placebo group. The study will be double-blind and continue for ten days, with the participants in the remdesivir group receiving 200 milligrams of remdesivir the first day and then another 100 mg each day for the nine remaining days.   

The placebo group will receive a similar solution to remdesivir at the same volume, but this solution will not have any active ingredients. 

An independent data and safety monitoring board (DSMB) will monitor ongoing results to ensure patient safety. On day 15, researchers will compare the two groups and unveil if remdesivir was affective. 

UNMC’s National Quarantine Unit is supported by the office of the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services (HHS). Clinical trial participants are cared for in the biocontainment unit. 

“We thank the individuals for their participation in this trial, and we are pleased that the NIH has chosen UNMC/ Nebraska Medicine as the site for this important work,” said Kalil. “Our expertise in treating highly infectious disease, as well as our capacity to conduct leading-edge clinical trials, will ensure that this trial is carried out in the most effective manner possible.”