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Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019.
Burwick, Richard M; Yawetz, Sigal; Stephenson, Kathryn E; Collier, Ai-Ris Y; Sen, Pritha; Blackburn, Brian G; Kojic, E Milunka; Hirshberg, Adi; Suarez, Jose F; Sobieszczyk, Magdalena E; Marks, Kristen M; Mazur, Shawn; Big, Cecilia; Manuel, Oriol; Morlin, Gregory; Rose, Suzanne J; Naqvi, Mariam; Goldfarb, Ilona T; DeZure, Adam; Telep, Laura; Tan, Susanna K; Zhao, Yang; Hahambis, Tom; Hindman, Jason; Chokkalingam, Anand P; Carter, Christoph; Das, Moupali; Osinusi, Anu O; Brainard, Diana M; Varughese, Tilly A; Kovalenko, Olga; Sims, Matthew D; Desai, Samit; Swamy, Geeta; Sheffield, Jeanne S; Zash, Rebecca; Short, William R.
  • Burwick RM; Cedars Sinai Medical Center, Obstetrics and Gynecology, Los Angeles, California, USA.
  • Yawetz S; Brigham and Women's Hospital, Department of Medicine, Boston, Massachusetts, USA.
  • Stephenson KE; Harvard Medical School, Boston, Massachusetts, USA.
  • Collier AY; Harvard Medical School, Boston, Massachusetts, USA.
  • Sen P; Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
  • Blackburn BG; Harvard Medical School, Boston, Massachusetts, USA.
  • Kojic EM; Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
  • Hirshberg A; Harvard Medical School, Boston, Massachusetts, USA.
  • Suarez JF; Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Sobieszczyk ME; Stanford University, Stanford, California, USA.
  • Marks KM; Mount Sinai Morningside and Mount Sinai West, New York, New York, USA.
  • Mazur S; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • Big C; Stanford University, Stanford, California, USA.
  • Manuel O; Columbia University, New York, New York, USA.
  • Morlin G; Weill Cornell Medicine, New York, New York, USA.
  • Rose SJ; NewYork Presbyterian/Weill Cornell Medical Center, New York, New York, USA.
  • Naqvi M; Beaumont Hospital, Dearborn, Michigan, USA.
  • Goldfarb IT; Lausanne University Hospital, Lausanne, Switzerland.
  • DeZure A; Valley Medical Center, Renton, Washington, USA.
  • Telep L; Stamford Health, Stamford, Connecticut, USA.
  • Tan SK; Cedars Sinai Medical Center, Obstetrics and Gynecology, Los Angeles, California, USA.
  • Zhao Y; Harvard Medical School, Boston, Massachusetts, USA.
  • Hahambis T; Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Hindman J; Gilead Sciences Inc, Foster City, California, USA.
  • Chokkalingam AP; Gilead Sciences Inc, Foster City, California, USA.
  • Carter C; Gilead Sciences Inc, Foster City, California, USA.
  • Das M; Gilead Sciences Inc, Foster City, California, USA.
  • Osinusi AO; Gilead Sciences Inc, Foster City, California, USA.
  • Brainard DM; Gilead Sciences Inc, Foster City, California, USA.
  • Varughese TA; Gilead Sciences Inc, Foster City, California, USA.
  • Kovalenko O; Gilead Sciences Inc, Foster City, California, USA.
  • Sims MD; Gilead Sciences Inc, Foster City, California, USA.
  • Desai S; Gilead Sciences Inc, Foster City, California, USA.
  • Swamy G; Gilead Sciences Inc, Foster City, California, USA.
  • Sheffield JS; Rutgers New Jersey Medical School, Newark, New Jersey, USA.
  • Zash R; Rutgers New Jersey Medical School, Newark, New Jersey, USA.
  • Short WR; Oakland University William Beaumont School of Medicine, Rochester, Michigan, USA.
Clin Infect Dis ; 73(11): e3996-e4004, 2021 12 06.
Article in English | MEDLINE | ID: covidwho-1562033
ABSTRACT

BACKGROUND:

Remdesivir is efficacious for severe coronavirus disease 2019 (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:

The reported data span 21 March to 16 June 2020 for hospitalized pregnant women with polymerase chain reaction-confirmed severe acute respiratory syndrome coronavirus 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 (200 mg on day 1, followed by 100 mg 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 (AEs) (16%). Most AEs were related to pregnancy and underlying disease; most laboratory abnormalities were grade 1 or 2. There was 1 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 AEs.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pregnancy Complications, Infectious / COVID-19 Drug Treatment Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Infant / Pregnancy Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: Cid

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pregnancy Complications, Infectious / COVID-19 Drug Treatment Type of study: Cohort study / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Infant / Pregnancy Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: Cid