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Update: Gilead has suspended access to the experimental drug remdesivir due to “overwhelming demand.” It is now only available through clinical trials at select sites. My hospital is one of them. Here’s how our trials are designed. I am an investigator on these phase 3 studies.
First trial is for severe disease, defined as 1) laboratory-confirmed COVID19 2) fever 3) abnormal chest x-ray and 4) oxygen saturation < 94% on room air. All patients receive remdesivir: 200mg IV loading dose, followed by 100mg IV once daily. 1:1 randomization to 5 days or 10.
Exclusion criteria: mechanical ventilation, multi-system organ failure, other experimental agents, including hydroxychloroquine in the past 24hrs.
Second trial is for moderate disease, defined as: 1) laboratory-confirmed COVID19 2) fever 3) abnormal chest x-ray, and oxygen saturation > 94% on room air. Randomization is 1:1:1 (remdesivir 10 days, remdesivir 5 days, local standard of care). Same exclusion criteria as above.
Enrollment began just hours after Gilead suspended access via compassionate use. Incredible teamwork by clinical investigators (led by Dr. Kristie Marks) and the Institutional Review Board to fast-track these vital studies. They need to make an emoji for a standing ovation.
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