Rapid response team helps launch first COVID-19 clinical trial

An IV bag filled with remdesivir

FNL provides behind-the-scenes support as ACTT tests multiple treatments for COVID-19

Teams from Frederick National Laboratory’s Clinical Monitoring Research Program Directorate facilitated the launch of the  Adaptive COVID-19 Treatment Trial (ACTT) and continue to support activities for the trial, which is sponsored by the National Institute of Allergy and Infectious Diseases  (NIAID),  part of the National Institutes  of Health

ACTT is the first clinical trial in the United  States  to evaluate  a n experimental treatment for COVID-19. It began enrolling patients in late February.  

Experienced team members, many of whom supported NIAID’s Ebola virus disease clinical trials in Liberia and the Democratic Republic of Congo, assisted NIAID in establishing 41 COVID-19 clinical sites in the United States; 27 of the 41 sites established by way of executed Clinical Trial Agreements. 

Early findings showed the study drug remdesivir helped hospitalized COVID-19 patients recover faster than those who received placebo. 

As the adaptive trial moves into additional studies, FNL continues to lead coordination and management of multi-site activities, regulatory approvals and contractual arrangements across the sites. The teams also coordinate logistics for supplies and materials to conduct the trials and maintain a 24-hour call center.

FNL support for COVID-19 trial reaches across the globe

ACTT-1 included multiple international sites, which successfully enrolled patients early in the pandemic. As many Americans crowded airports in the rush home to avoid the coronavirus, FNL rapid response team members boarded a plane in February to travel halfway across the world to fight it. 

The team guided research staff in obtaining required regulatory approvals from regulators in South Korea, Japan, Mexico, and Europe; coordinated training for research staff and, where needed, imported the supplies needed to conduct the trial. 

FNL continues to support the international sites in the study.