Every time a patient with COVID-19 is admitted to the Brigham, a team is working behind the scenes to help match patients to cutting-edge care made possible through clinical trials. There are currently no therapeutics approved by the Food and Drug Administration (FDA) for the treatment of COVID-19, but at the Brigham, clinical trials of an antiviral drug are underway.
Rama Al Hamed, MD, is a research fellow who, along with two other fellows and three research assistants, tracks COVID-19 patients, reviews their medical records and helps flag eligible patients that a co-investigator can approach about participating in trials of the drug remdesivir.
“We’re working harmoniously to get the job done as efficiently as possible. This pandemic is evolving quickly but we’re moving quickly too,” said Al Hamed, who will be starting her residency in internal medicine at Albert Einstein College of Medicine in the fall.
On March 21, the Brigham began enrolling patients in two clinical trials for Gilead’s antiviral medication remdesivir. The Brigham is one of multiple clinical trial sites for Gilead-initiated studies of the drug in 600 participants with moderate COVID-19 and 1400 participants with severe COVID-19.
“We anticipate that results may be available in the next two months,” said Francisco Marty, MD, a physician in the Brigham’s Division of Infectious Disease who is the principal investigator for the trial. “If the results are promising, this could lead to FDA approval, and if they aren’t, it gives us critical information in the fight against COVID-19 and allows us to move on to other therapies.”
Remdesivir is an investigational broad-spectrum antiviral medication that has not been approved for any use. The drug was originally developed with the goal of treating Ebola virus disease and Marburg virus infection but has shown activity against other viruses in animal models.
Behind the Scenes
Emily Silverman is a research coordinator for Marty’s team. Silverman graduated from college last May and will be starting medical school in the fall. She joined Marty’s team about 10 months ago and was previously helping on clinical trials unrelated to the coronavirus. Then, everything changed. While continuing to keep essential clinical trials going, Silverman and the rest of the team are also hard at work behind the scenes to make the remdesivir trials possible at the Brigham. In coordination and cooperation with the rest of the research team, Silverman logs data and keeps checklists for every patient enrolled in the trial, each of whom requires daily visits and treatment. She briefs Marty or co-investigators before they go the clinical floors to see patients enrolled in the trials.
“I’m so grateful to work at a hospital that has the capacity to offer patients treatment through clinical trials,” said Silverman. “I just happened to be in this job at this moment. Anyone who goes into medicine wants to provide the best possible care to patients who need it. Whatever role I can play toward that goal is so meaningful to me.”
The randomized, open-label phase 3 trials will evaluate the safety and efficacy of remdesivir compared to standard of care. For the trial of severe patients, the primary outcomes will be the normalization of temperature and oxygen saturation through day 14; in the trial of moderate patients, the primary outcome will be time to discharge. Patients will be randomized to either a 5-day or 10-day regimen of remdesivir in addition to standard of care. Other trials, including a placebo-controlled clinical trial organized by the National Institutes of Health, are underway at other sites.
“All of us would rather be working in the clinic seeing patients — that’s what we’d been doing and what we want to get back to doing,” said Al Hamed. “All of us, in research and in the clinic, are motivated by the potential to help others. There is nothing better than getting to see a patient discharged. This is what drives us.”