The entire FHI Clinical team is thrilled to support the development of multiple different COVID-19 therapies that offer patients safe, effective treatment options during the ongoing pandemic and beyond.
Since early in the pandemic, we have been working with the Adaptive COVID-19 Treatment Trial (ACTT) team. This series of four Phase 3, randomized, double-blind, placebo-controlled trials is being conducted by the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the clinical efficacy and safety of putative investigational therapeutic agents among hospitalized adults with laboratory-confirmed COVID-19. All four trials have ceased enrolling patients, and three trials are completed. Close-out visits and database lock are underway for the fourth study, ACTT-4.
TRIAL: ACTT-1 | |
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Investigational Therapies | Remdesivir vs placebo |
Outcomes | 10-day course of remdesivir performed better than placebo in treating hospitalized patients with COVID-19. Emergency Use Authorization (EUA) was granted by the U.S. Food & Drug Administration (FDA). |
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Sample Size | 1,062 patients at 60 sites |
TRIAL: ACTT-2 | |
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Investigational Therapies | Remdesivir + baricitinib vs remdesivir |
Outcomes | Combination baricitinib and remdesivir was superior at shortening recovery time and improving clinical status in adults hospitalized with COVID-19, particularly for those who were receiving high-flow oxygen or noninvasive ventilation. |
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Sample Size | 1,033 patients at 71 sites |
TRIAL: ACTT-3 | |
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Investigational Therapies | Remdesivir + interferon beta-1a vs remdesivir |
Outcomes | Interferon beta-1a plus remdesivir was not associated with a clinical benefit over remdesivir alone in hospitalized adults with COVID-19. |
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Sample Size | 969 patients at 64 sites |
TRIAL: ACTT-4 | |
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Investigational Therapies | Remdesivir + baricitinib vs remdesivir + dexamethasone |
Outcomes | Enrollment ended early due to a data and safety monitoring board (DSMB) decision that it met the pre-defined futility criteria for stopping the study. |
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Sample Size | 1,010 patients at 67 sites |
Our team, led by Leigh Anne Blackmon, worked directly with the sites to collect regulatory documents during the fast-paced site activation process. As the studies rapidly wrap up, our team is also responsible for the trial master files (TMFs) and TMF archival for each of the four studies, which has required careful consideration of how best to organize the data. Some information is shared across the four studies, but a separate TMF is still required for each study; while it is necessary to ensure information is available for a potential inspection, it is also important to minimize duplication between TMFs.
These studies are providing important information about effective treatments for the clinical management of hospitalized patients with COVID-19, and we’re proud to have contributed to the rapid data collection and study close-out to ensure that the results can be shared with the medical community worldwide.
