The first clinical trial in the US to evaluate an experimental treatment for coronavirus disease in humans is now underway at the University of Nebraska.
The first clinical trial in the US to examine an investigational antiviral drug for the coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center in Omaha.
Researchers at the National Institute of Allergy and Infectious Diseases (NIAID)-part of the National Institutes of Health (NIH)-are conducting the randomized, double-blind, controlled clinical trial to evaluate the safety and efficacy of remdesivir (Gilead Sciences Inc.) in hospitalized adults diagnosed 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 Anthony S. Fauci, MD, NIAID Director and US Coronavirus Task Force member in a NIH press release. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
Remdesivir, an investigational broad-spectrum antiviral agent, has previously been tested in humans with Ebola virus disease, the press release noted, and has shown promise in animal models for Middle East respiratory syndrome and severe acute respiratory syndrome, both caused by other coronaviruses.
Announcement made amidst pandemic possibility
The NIH published the press release on Tuesday, February 25, 2020 – the same day the Centers for Disease Control and Prevention (CDC) held a telebriefing warning Americans that health experts are anticipating COVID-19 to spread in the US.
“We expect we will see community spread in this country,” said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases in the telebriefing. “It’s not so much a question of if this will happen anymore, but rather more a question of exactly when this will happen and how many people in this country will have severe illness.”
As of February 25, the World Health Organization (WHO) reported 80 239 confirmed cases of COVID-19 globally; 77 780 in China and 2459 outside of China.
In the US there have been 14 confirmed cases of COVID-19, 12 of those being travel-related, as of February 26.
What does this new clinical trial entail?
NIAID researchers took into account the ongoing clinical trials of remdesivir in China when designing the current study and are proceeding in accordance with consultations assembled by the WHO on the development of a trial for COVID-19.
The first volunteer to participate in the study is an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan.
“It’s not so much a question of if this will happen anymore, but rather more a question of exactly when this will happen and how many people in this country will have severe illness.”
Participants must have laboratory-confirmed COVID-19 and evidence of lung involvement with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation. Those with confirmed infection, but with mild, cold-like symptoms or no apparent symptoms will not be included in the study. All potential participants will undergo a baseline physical exam before treatment.
Eligible participants will be randomly assigned to either the investigational treatment group or the placebo group.
The investigational treatment group will receive 200 mg of remdesivir intravenously on the first day of enrollment and then another 100 mg each day for the duration of hospitalization (up to 10 days total). The placebo group will receive a remdesivir-like solution with inactive ingredients at an equal volume.
“Clinicians will regularly monitor participants and will assign them daily scores based on a predefined scale of clinical outcomes that considers factors such as temperature, blood pressure and use of supplemental oxygen, among others,” the NIH press release noted.
Blood samples as well as nose and throat swabs will be taken approximately every 2 days for COVID-19 testing. To determine if remdesivir increased clinical benefit vs placebo, researchers will initially compare outcomes from both groups on day 15.
Outcomes will be scored on a 7-point scale ranging from fully recovered to deceased and this scale will be reevaluated after researchers review data from first 100 patients. The study can also be adapted at other US and global sites to evaluate additional investigative treatments.
“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 lead author Andre Kalil, MD, in the NIH press release. “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.”