COVID-19 Trials Opening at Accelerated Rate
PHILADELPHIA – Michael Baram, MD, and other pulmonary researchers at Thomas Jefferson University partnered with the Jefferson Clinical Research Institute (JCRI) to get one of the first COVID-19 related clinical trials up and running in record time at Thomas Jefferson University.
This Phase 2/3 study, sponsored by Biohaven Pharmaceuticals, will evaluate the safety and efficacy of Vazegepant in patients hospitalized with COVID-19 who require supplemental oxygen. Although this intranasal spray is being investigated for use in acute migraine, researchers have reason to believe it may improve outcomes from patients with COVID-19. The drug targets and blocks an enzyme that’s thought to cause inflammation in the brain. Vazegepant has the potential to reduce inflammation in the part of the lungs responsible for air exchange, which may lead to improved outcomes in COVID-19 patients.
Details about this trial can be found atCclinicalTrials.gov by searching for trial number: NCT04346615.
Typically, it can take up to 90 days to finalize regulatory and contracting requirements—but this trial was open to enrollment in just 2 weeks. The trial began enrolling patients April 21.
“This is just another example of how employees across the enterprise are putting in extra effort to help combat the devastating effects of this pandemic,” says Michael Baram. “Our regulatory and contracting teams, our IRB, IDS, and our research nurses and coordinators all pulled extra time to get this trial to patients faster. It was an incredible team effort.”
Patients will be given the option to enroll in the study if they are in treatment for COVID-19, but not yet on a respirator. Currently, Jefferson is the sole site recruiting for this clinical trial.