Aimed at reaching 400 “recovered” participants,
the NIH’s National Institute of Allergy and Infectious Diseases (NIAID)
has increased the enrollment target to 572, about double the original estimate, in its Phase 3 clinical trial evaluating Gilead Sciences’ (GILD -1.2%) antiviral remdesivir in hospitalized COVID-19 patients.
The study, to be conducted across ~100 sites
globally, will compare the treatment arm (200 mg/day followed by 100
mg/day for up to 10 days) to a control arm.
The primary endpoint is the time to recovery by
day 29. Time to recovery is defined as the achievement of one of the
following: hospitalized but not requiring supplemental oxygen and no
longer requiring ongoing medical care, not hospitalized but limited on
activities and/or requiring home oxygen or not hospitalized with no
activity limitations.
The estimated completion date is April 2023.
https://seekingalpha.com/news/3564214-niaid-boosts-enrollment-in-remdesivir-study
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