High Rates of Clinical Recovery with Remdesivir in Pregnant Women Hospitalized with Severe COVID-19

30 Oct, 20

Introduction

Compared to age matched non-pregnant women with Covid-19, pregnant women are more likely to be hospitalized and require mechanical ventilation. There is limited data on the efficacy of remdesivir in pregnant women, as they have been excluded from clinical trials. However, this drug has been available for use in pregnant women with severe Covid-19 through the emergency-use authorization (EUA) as of May 1, 2020.

Aim

This study assessed the clinical efficacy and safety of compassionate use of intravenous remdesivir in the first 86 pregnant women hospitalized with severe COVID-19.

Methods

Study Design

Compassionate use program

Treatment Strategy

Hospitalized pregnant women with PCR-confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Room air oxygen saturation <94% OR need for oxygen support
Patients with creatinine clearance of <30 ml per minute, serum levels of alanine aminotransferase (ALT) >5 times the upper limit of normal, or evidence of multi-organ failure were excluded.
Cohort received intravenous remdesivir 200 mg on day 1, followed by 100 mg daily from days 2 to 10
Out of the total 86 women, 19 had already delivered before receiving remdesivir and are referred to as the immediate ‘postpartum’ group

Endpoints

Recovery, defined as discharge for the women on room air at baseline and improving to room air or discharge in case of women who were hypoxic and on oxygen support at baseline
Time to extubation in women on invasive mechanical ventilation
Changes in oxygen status
Pregnancy outcomes
Adverse events (AEs)
Serious adverse events (SAEs)

Results

Out of the total 86 women, 67 women received remdesivir while they were pregnant and 19 women during immediate postpartum period
Invasive ventilation was required by 40% of pregnant women (median gestational age 28 weeks) as compared to 95% of postpartum women (median gestational age at delivery 30 weeks) at baseline
Median duration of symptoms prior to hospitalization was nine days, and median duration of hospitalization prior to initiation of remdesivir was three days, in both group
The clinical outcomes by day 28 of follow-up are summarized in Table 1.

Table 1. Summary of clinical outcomes

	Pregnant women	Postpartum women
Recovery rate	93%	90%
Discharged	90%	84%
Any clinical improvement	96%	89%
2-point clinical improvement	93%	90%
Level of oxygen requirement decreased	96%	89%
Extubation rate	93%	89%

The highest rates of clinical improvement were demonstrated in the pregnant women not requiring invasive ventilation (98% recovered, 95% discharged 98% had clinical improvement)
Among pregnant women, median time to recovery was 5 days for those not on invasive ventilation and 13 days for those on invasive ventilation
Out of a total of 45 deliveries, 82% were caesarean and 86% of these were emergent caesarean
The postpartum women had a higher rate of caesarean delivery as compared to pregnant women (95% vs 73%)
Among the 45 deliveries, there were no neonatal deaths during the observation period.
Remdesivir was well tolerated, with a low incidence of AEs (29%) and serious AEs (16%)
Most AEs were related to pregnancy and underlying disease; most laboratory abnormalities were Grades 1 or 2
One woman died in the postpartum period due to severe acute respiratory distress syndrome and associated cytokine storm

Conclusion

Compassionate use of remdesivir in pregnant and postpartum women hospitalized with severe Covid-19 was associated with high clinical recovery rates and was safe and well tolerated.

Clin Infect Dis. 2020 Oct, ciaa 1466. Doi: 10.1093/cid/ciaa1466.