The Frederick National Laboratory for Cancer research (operated by Leidos Biomedical Research) has selected contract research organization FHI Clinical for its Adaptive COVID-19 Treatment Trial (ACCT). The adaptive study is designed to enable investigation of putative therapeutics, for the treatment of COVID-19 in hospitalized adults.
Claudia Christian, senior vice president for clinical operations with FHI Clinical told Outsourcing-Pharma that the CRO has worked with Leidos Biomedical and the National Institute of Allergy and Infectious Diseases (NIAID) in the past.
“This collaborative partnership has allowed us to deploy our staff in response to the Ebola DRC outbreak and the ChikV program across the Americas. Additionally, we often find ourselves as part of a larger team such as in the recent completion of a Zika vaccine program,” she said.
The ongoing ACTT study is a randomized, double-blinded, placebo-controlled trial supported by NIAID, part of the National Institutes of Health. Preliminary results of the first iteration from ACTT-1 (published in the New England Journal of Medicine (NEJM) included 1,063 participants recruited within an eight-week period at 60 study sites and 13 subsites in Europe and the US.
According to Danielle Fisher, associate director of clinical operations, FHI Clinical’s scope of work includes a variety of services:
- Site management
- Meeting logistics
- 24/7 call center
- Trial master file management
In the trial’s first iteration of the trial, staff administered intravenous remdesivir or placebo 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 showed 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 reportedly similar between the groups.
The next iteration of the study, known as ACTT-2, is now open. New participants will be receiving remdesivir, plus the anti-inflammatory drug baricitinib or remdesivir alone.
FHI Clinical study team members Fisher and Wendi McDonald, clinical research associate, are listed in the NEJM paper for their contributions to the study. A new paper is slated to be published in the journal after follow-up is complete and results from the full analyses are available.
Christian told us that this and other clients have turned to FHI Clinical in part before of its solutions already in place to support emergency response.
"Specifically, during this outbreak, we have deployed a robust REMOTE site selection and initiation training program. While our SMAs have carried the majority of the site management activities, our field CRAs have joined in with virtual monitoring,” she said.
“We have been helping our sponsors stay abreast of the changing EPI landscape and shifting standard of care so they can make the most informed decisions about their protocol execution,” she added. “We are keeping them at the forefront of how to best execute their study while adhering to regulatory requirements around expedited start-up processes and acceptable informed consent methodology.”