Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019

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.

Does Lung Ultrasound Have a Role in the Clinical Management of Pregnant Women with SARS COV2 Infection?

“…On the other hand, other studies have found that SARS-CoV-2 infection during pregnancy could compromise its course, being frequently associated with a worse obstetric outcome if compared with unaffected women at the same gestational age [62,63]. According to recent scientific evidence, it seems that the presence of previous maternal risk factors; such as an age > 35 years, a BMI > 30, a chronic hypertension or a pre-existing diabetes could be responsible of a worse clinical course, leading to a higher rate of admission in intensity care unit (ICU) [19,64,65]. In our research we have excluded patients with a BMI > 30 and/or age > 45 years because we wanted to reduce the risk of other gestational comorbidities, like diabetes, hypertension and pre-eclampsia which could worsen the clinical course of the infection.…”

“…She was treated with the therapeutic protocol for SARS-CoV-2 pneumonia of our hospital, including remdesivir immediately after delivery. Remdesivir was chosen because it has been recently approved by FDA as a promising and safe antiviral drug against SARS-CoV2 in patients with severe respiratory symptoms; indeed, there are some preliminary reports showing that it could be safe and well tolerated also in pregnancy [65].…”

New Perspectives on Antimicrobial Agents: Remdesivir Treatment for COVID-19

“…Pregnant women not requiring invasive ventilation at baseline had the highest rates of recovery (98%) and shortest median time to recovery (5 days); among those women, 98% recovered and 95% were discharged. Treatment with remdesivir was well tolerated; no new safety signals were detected among pregnant patients ( 46 ). Overall, remdesivir should be used during pregnancy only if the potential benefit justifies the potential risks for mother and fetus.…”

Management and Prevention of COVID-19 in Pregnancy and Pandemic Obstetric Care: A Review of Current Practices

“…However, there is insufficient evidence for its safety during pregnancy, mainly due to its unknown risk of transplacental transfer [ 55 , 56 ]. Most relevant trials have excluded pregnant and breastfeeding women, although high recovery rates were observed in pregnant women who received compassionate use of remdesivir [ 57 ]. Therefore, standard-of-care administration of remdesivir in pregnant women with COVID-19 should be currently avoided [ 42 , 56 ].…”