Summary of available clinical trial data
Trial Name/NCT No. | Study Design | N, Population | eGFR Cutoff | Remdesivir Duration, d | Outcomes |
---|---|---|---|---|---|
NIAID ACTT-1 study | Double-blind, placebo-controlled RCT | 1063 hospitalized adult patients, international | 30 | 10 | Interim analysis: median time to recovery 11 versus 15 d; P<0.001; mortality 8% versus 11.6%; P=0.06 |
NCT04292899 | Randomized, open-label trial | 197 adults with severe COVID-19, international | 50 | 5 versus 10 | 70% clinical recovery and 59% clinical recovery by 14 d in 5- and 10-d groups |
Compassionate use program | Open label, multicenter, nonrandomized | >1200 adults, 76 children with COVID-19, international | 30 | 10 | Report of 61 treated patients, 8 lost to follow-up; 36 of 53 improved at a median follow-up of 18 d2 |
NCT04257656 | Double-blind, placebo-controlled RCT | 237 adults with severe COVID-19, China | 30 | 10 | No difference in time to clinical improvement; equivalent number of renal AEs in placebo and remdesivir arms3 |
In all cases, remdesivir dosing begins with a 200-mg intravenous loading dose followed by 100 mg intravenously daily. Currently available clinical trial data supporting remdesivir use are shown. NCT, national clinical trial; NIAID ACTT-1, National Institute of Allergy and Infectious Diseases Adaptive Covid-19 Treatment Trial; RCT, randomized, controlled trial; AE, adverse event.