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Adults with severe symptoms of the novel illness will have the opportunity to participate in Duke University Hospital’s test of an investigational treatment with an antiviral agent known as remdesivir.
Remdesivir is an antiviral agent that was previously tested in humans with Ebola virus disease and has shown promise in animal studies against MERS and SARS, diseases that emerged from different strains of the coronavirus.
Duke is ready to begin enrolling patients who meet certain qualifications. All potential participants will undergo a baseline physical exam before receiving treatment and must have significant symptoms such as difficulty breathing, using supplemental oxygen or needing mechanical ventilation.
“This trial is limited to people who are in the hospital with severe symptoms because most people with COVID-19 will recover safely at home with no need for therapies,” said Emmanuel Chip Walter, M.D., who is a co-investigator on the study.
“We do not want to expose people with mild or no symptoms to a therapy that could have potential side effects,” he said.
Currently, there are no approved therapies for COVID-19. Duke officials said they are eager to contribute in any way to help find ways to fight this global pandemic
“Duke’s participation in this national study creates an extra option for potential patients in our community who have serious complications from COVID-19,” said Cameron Wolfe, M.D., the study’s principal investigator.
HOW THE STUDY WORKS
Participants in the study, designed to evaluate the safety and effectiveness of remdesivir, will be randomly assigned to either receive the therapy or a mock treatment. To assure the results are not biased, patients and their doctors will not know who receives the active therapy.
Participants in the investigational treatment group will receive a daily intravenous dosage of remdesivir for up to 10 days. The placebo group will receive a similar administration of inactive ingredients. Patients will be assessed daily for measurable changes in their conditions.
Officials said trial data will be pooled from all the participating clinical sites roughly mid-way through the enrollment period and analyzed to determine whether changes should be made to the study’s design.
If, at that midpoint, patients showed no benefit, the study could be halted, or revised to add another therapy that might boost the response.
“We need to be able to move quickly, and this sort of study design will help us understand sooner rather than later whether the therapy is beneficial,” Walter said.
The study is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and managed by the Frederick National Laboratory for Cancer Research. Gilead Sciences Inc. developed remdesivir and is supplying it for the study.
“Facing an urgent need to find treatments for COVID-19, we are able to rely on decades of collaborative work among the many talented teams at Duke to advance the knowledge and treatment of infectious diseases,” said Mary E. Klotman, M.D., dean of the Duke University School of Medicine.