Compassionate Use of Remdesivir in Pregnant Women with Severe Covid-19.

Richard M Burwick
Sigal Yawetz
Kathryn E Stephenson
Ai-Ris Y Collier
Pritha Sen
Brian G Blackburn
E Milunka Kojic
Adi Hirshberg
Jose F Suarez
Magdalena E Sobieszczyk
Kristen M Marks
Shawn Mazur
Cecilia Big, Beaumont Health
Oriol Manuel
Gregory Morlin
Suzanne J Rose
Mariam Naqvi
Ilona T Goldfarb
Adam DeZure
Laura Telep
Susanna K Tan
Yang Zhao
Tom Hahambis
Jason Hindman
Anand P Chokkalingam
Christoph Carter
Moupali Das
Anu O Osinusi
Diana M Brainard
Tilly A Varughese
Olga Kovalenko
Matthew D Sims, Beaumont Health
Samit Desai
Geeta Swamy
Jeanne S Sheffield
Rebecca Zash
William R Short

Abstract

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.