Mega Doctor News
By Duke Clinical Research Institute
Newswise — DURHAM, N.C. – A study led by the Duke Clinical Research Institute (DCRI) in partnership with Vanderbilt University found no symptomatic or clinical benefit to taking fluticasone furoate for the treatment of mild-to-moderate COVID-19 symptoms.
“There was no evidence of improvement in time to recovery or reduction in hospitalizations in participants who took fluticasone furoate versus those who took a placebo,” said Adrian Hernandez, M.D., the study’s administrative principal investigator and executive director of the DCRI.
Findings appear on medRxiv, a pre-publication server, and have been submitted to a peer-reviewed journal.
ACTIV-6 — “The Randomized Trial to Evaluate Efficacy of Repurposed Medications” — is a nationwide double-blind study that has nearly 5,000 participants. The trial continues to enroll with plans to include thousands of participants from across the United States to evaluate the potential benefits for treating mild-to-moderate COVID-19 with repurposed medications.
Repurposed medications are those already approved by the U.S. Food and Drug Administration (FDA) for other medical indications. Fluticasone furoate is one of three FDA-approved repurposed medications currently being tested in ACTIV-6.
Fluticasone furoate is an orally inhaled corticosteroid indicated for once-daily maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. It is not approved by the FDA to treat COVID-19 and should only be taken as prescribed or as part of a clinical trial. Fluticasone furoate was chosen for this study because inhaled corticosteroids had shown potential for treating COVID-19 in the outpatient setting.
The fluticasone furoate arm of the study opened in June 2021 and enrolled 1,127 participants across the United States in eight months. During the study, participants either took a dose of 200 mcg per day of fluticasone or used a matching placebo inhaler for 14 days.
“No safety concerns were identified in this arm of the study, confirming that fluticasone furoate is safe to take as prescribed per the FDA for the treatment of asthma or other approved conditions,” said Susanna Naggie, M.D., the DCRI principal investigator overseeing the study’s clinical coordinating center. “ACTIV-6 continues to enroll into other medication arms and may add additional arms as the study progresses.”
In addition to Drs. Hernandez and Naggie, members of the ACTIV-6 Executive Committee include Stacey Adam, David Boulware, Sean Collins, Allison DeLong, Sarah Dunsmore, G. Michael Felker, George Hanna, Chris Lindsell, Matthew McCarthy, Gene Passamani, April Remaly, Elizabeth Shenkman, Thomas Stewart, Florence Thicklin, Rhonda Wilder, and Sybil Wilson.
ACTIV-6 (ClinicalTrials.gov identifier NCT04885530) received funding from the National Institutes of Health (3U24TR001608-06S1).
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About ACTIV-6
ACTIV-6 is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and is led by the National Center for Advancing Translational Sciences (NCATS). The DCRI serves as the study’s clinical coordinating center, partnering with Vanderbilt University Medical Center as the study’s data coordinating center. The study is leveraging the infrastructure of PCORnet®, the National Patient-Centered Clinical Research Network, supported by the Patient-Centered Outcomes Research Institute, and the Trial Innovation Network, a collaborative initiative within the NCATS Clinical and Translational Science Awards Program that helps address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies.
About the Duke Clinical Research Institute
The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization in the world. Our mission is to develop, share, and implement knowledge that improves global health through innovative clinical research. The institute conducts multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. The DCRI is a pioneer in cardiovascular and pediatric clinical research, and conducts groundbreaking clinical research across multiple other therapeutic areas, including infectious disease, neuroscience, respiratory medicine, and nephrology. The DCRI is also involved with other ACTIV studies, serving as the U.S. coordinating center for ACTIV-1, a COVID-19 master protocol study testing immune modulators, and participating in ACTIV-4, which is examining optimal use of oral anticoagulants to prevent COVID-19-associated blood clots.
