Bassett Launches COVID MED Clinical Trial for Patients
In a press release on Wednesday, Bassett Medical Center announced that they have started an investigator-initiated clinical trial assessing the safety and efficacy of several medications as potential treatments for COVID- 19 among hospitalized patients. The trial was designed by the hospital’s Department of Medicine and the Bassett Research Institute, and is funded by the E. Donnall Thomas Resident Research Program. The study, named COVID MED, includes only patients with laboratory confirmed COVID-19 infection who are hospitalized at Bassett Medical Center in Cooperstown or A.O. Fox Hospital in Oneonta. Other qualifying institutions nationwide have been invited to join the trial.
There are currently no approved treatments for COVID-19. Potential therapies have been identified, but there is no evidence of clinical benefit with any of these therapies. Both the Centers for Disease Control and Prevention (CDC) and New York State Department of Health (NYSDOH) have stressed the need to test these drugs in the context of clinical trials. The CDC has recommended that clinical trials be performed to determine the benefit, if any, of these medications. While all of these medications are FDA approved for other indications, their efficacy in treating COVID-19 has not been established.
Governor Andrew Cuomo previously issued an executive order prohibiting pharmacists from dispensing one of these drugs, hydroxychloroquine, outside its approved, labeled indications or outside the context of a state-approved clinical trial. The NYSDOH is aware and supportive of Bassett’s COVID MED clinical trial.
This clinical trial is listed on a federal register of clinical trials (clinicaltrials.gov) that enables other institutions to learn about and join the trial. This trial was designed as a multisite study; thus, it will require other institutions in the U.S. to join in order to recruit the large number of patients needed to statistically power the study. Patients must be hospitalized less than 72 hours in order to be enrolled; up to 4,000 patients can be accepted into the Bassett COVID MED clinical trial.