Compassionate Use of Remdesivir in Pregnant Women with Severe Covid-19.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
BACKGROUND: Remdesivir is efficacious for severe COVID-19 in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir.
METHODS: Reported data span March 21 to June 16, 2020 for hospitalized pregnant women with PCR-confirmed SARS-CoV-2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through the compassionate use program. The intended remdesivir treatment course was 10 days (200mg on Day 1, followed by 100mg for Days 2-10, given intravenously).
RESULTS: Nineteen of 86 women delivered before their first dose and were reclassified as immediate "postpartum" (median postpartum day=1; range 0-3). At baseline, 40% of pregnant women (median gestational age 28 weeks) required invasive ventilation, in contrast to 95% of postpartum women (median gestational age at delivery 30 weeks). By Day 28 of follow-up, the level of oxygen requirement decreased in 96% and 89% of pregnant and postpartum women, respectively. Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged. Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. Remdesivir was well tolerated, with a low incidence of serious adverse events (16%). Most adverse events were related to pregnancy and underlying disease; most laboratory abnormalities were Grades 1 or 2. There was one maternal death attributed to underlying disease and no neonatal deaths.
CONCLUSIONS: Among 86 pregnant and postpartum women with severe COVID-19 who received compassionate use remdesivir, recovery rates were high, with a low rate of serious adverse events.
Burwick RM, Yawetz S, Stephenson KE, Collier AY, Sen P, Blackburn BG, Kojic EM, Hirshberg A, Suarez JF, Sobieszczyk ME, Marks KM, Mazur S, Big C, Manuel O, Morlin G, Rose SJ, Naqvi M, Goldfarb IT, DeZure A, Telep L, Tan SK, Zhao Y, Hahambis T, Hindman J, Chokkalingam AP, Carter C, Das M, Osinusi AO, Brainard DM, Varughese TA, Kovalenko O, Sims MD, Desai S, Swamy G, Sheffield JS, Zash R, Short WR. Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019. Clin Infect Dis. 2021 Dec 6;73(11):e3996-e4004. doi: 10.1093/cid/ciaa1466. PMID: 33031500; PMCID: PMC7797739.