Investigators with Dartmouth-Hitchcock (D-H) research operations launched two Phase III clinical trials in record time—condensing the amount of time required for study start up from 60 days or more down to six days. An impressive accomplishment—but needed, as the studies deal with COVID-19. The East Coast, especially New York City metropolitan area, has been hit hard by the pandemic. Therapeutic help is needed—now. Both of the clinical trials assess remdesivir; one on patients with moderate COVID-19 symptoms and the other deals with patients afflicted with severe advanced symptoms.
The State of New Hampshire’s only academic medical center, Dartmouth-Hitchcock Medical Center (DHMC) lies in the heart of the Upper Connecticut River Valley. DHMC recently signed on to participate in major remdesivir clinical trials as the pandemic rages on particularly hard to the south in New York. By conducting these Phase III clinical trials, investigators and sponsor will collect data and insights in regard to the safety and effectiveness of remdesivir by investigating different population segments, varying dosages as well as the use of remdesivir in combination with other therapies, reports DHMC via its updated news site.
DHMC Readies Clinical Trial in Record Time
As a dangerous pandemic has unfolded, DHMC had to move into rapid implementation mode to ready staff and facility for the clinical trials. They needed to rapidly ready about 25 nurses who underwent fit testing for personal protective equipment to participate in managing the trial on inpatient units, where the drug will be administered intravenously, reported Richard Zuckman, MD, MPH, with DHMC’s Section of Infectious Disease and International Health.
DHMC’s ability to move so quickly comes from orders at the top as Leigh Burgess, vice president of DHMC’s Research Operations, noted COVID-19 research is at the top of the priority list. Ms. Burgess noted, “As an academic medical center we have the tools and the teams to address this evolving situation. Special acknowledgement and thanks to the teams that worked together to open this study quickly and offer these important options for our patients.”
DHMC is assessing patient eligibility/admission or screening of in-house patients who test positive for the virus and meet the eligibility criteria.
The study drug, remdesivir, is one of the leading anti-viral candidates for addressing COVID-19. The drug was originally developed and used during the West African Ebola virus from 2013 to 2016. Remdesivir was also identified as a promising drug against Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Currently, Gilead is supplying the drug for several clinical trials that have been activated and streamlined to deal with the global COVID-19 pandemic.
Leigh Burgess, vice president of DHMC’s Research Operations
Richard Zuckerman, MD, Infectious Disease and International HealthSource: Dartmouth-Hitchcock