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Friday, April 24, 2020

NIAID boosts enrollment in remdesivir study

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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