FHI Clinical Inc. has announced that it has a subcontract with the Frederick National Laboratory for Cancer Research, currently operated by Leidos Biomedical Research, Inc., to provide clinical operations services for the Adaptive COVID-19 Treatment Trial (ACTT). ACTT is an adaptive study to allow investigation of putative therapeutics, for the treatment of COVID-19 in hospitalized adults.
Supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, the ongoing ACTT study is a randomized, double-blinded, placebo-controlled trial. Preliminary results of the first iteration from ACTT-1 were published in the New England Journal of Medicine (NEJM) for 1,063 participants recruited within an eight-week period at 60 study sites and 13 subsites in Denmark, Germany, Greece, Japan, Korea, Mexico, Singapore, Spain, the United Kingdom and the United States.
The FHI Clinical team provides a variety of clinical operations services and expertise for this study, including trial master file (TMF) management, site management tasks such as regulatory document collection, operational communications and responses, study team meeting coordination, and 24/7 call center oversight and staffing.
In this first iteration of the trial, in addition to standard care, intravenous remdesivir or placebo was administered for up to 10 days to determine the effect on recovery time. Due to the rapid enrollment pace, an interim review by the Data and Safety Monitoring Board (DSMB) occurred after enrollment was completed but while follow-up was ongoing.
The preliminary analysis demonstrated that adults hospitalized with COVID-19 receiving remdesivir showed shorter time to recovery, 11 days compared with 15 days for the placebo group, as well as lower mortality rates. The rates of adverse events were similar between the groups.
The next iteration of the study, known as ACTT-2, is now open, and new participants are receiving remdesivir plus an anti-inflammatory drug (baricitinib) or remdesivir alone.
“The FHI Clinical team is excited to be part of this important work to find efficacious and safe treatments for COVID-19,” said Ted FitzGerald, FHI Clinical president and CEO. “Our team was able to jump in and make an immediate impact given our extensive experience managing studies around the globe.”
Of the FHI Clinical study team members, Danielle Fisher, Associate Director of Clinical Operations, and Wendi McDonald, Clinical Research Associate, are listed in the NEJM paper for their contributions to the study. A new paper will be published in the NEJM once follow-up is complete and results from the full analyses are available.
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This project was funded, in whole with federal funds from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), under 75N91019D00024.