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      Compassionate Use of Remdesivir in Pregnancy: A Case Series From a COVID-19 Dedicated Center and Review of Literature

      case-report
      1 , , 2 , 3 , 4 , 1 , 1
      ,
      Cureus
      Cureus
      sars-cov-2, prone positioning, tocilizumab, covid-19, pregnancy, remdesivir

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          Abstract

          Pregnancy is associated with immunological changes that could render an individual vulnerable to the severe coronavirus disease 2019 (COVID-19) disease. Even as we witnessed the third and most widespread pandemic wave, a conclusively advantageous treatment option still remained elusive. Remdesivir was one of the front-running therapeutic options that received emergency use authorization (EUA) and subsequent approval for the management of moderate to severe COVID-19 infections. Here, we report a series of moderate to severe COVID-19-infected pregnancies and the experience of remdesivir use on a compassionate basis. Four cases of pregnancy complicated with moderate to severe COVID-19 infections where remdesivir was administered were recruited into the study, and their outcome was assessed objectively. Of these cases, three women received remdesivir in addition to standard SARS-CoV-2 treatment in the antenatal period. One woman received remdesivir after delivery. One woman received tocilizumab in addition to remdesivir and standard SARS-CoV-2 care. Two women survived and were subsequently discharged to home care. Two succumbed to the disease. One baby who was exposed to remdesivir in utero is doing well at six months post-delivery. Remdesivir had been granted EUA for the treatment of suspected or laboratory-confirmed COVID-19 infection in adults and children who were hospitalized with severe disease or requiring supplemental oxygen and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) in May 2020. This issuance allowed the use of the same dosing regimen in pregnant and parturient women as in the general adult population. Thus, this series of cases tried to assess the outcome of this drug among COVID-19-infected pregnant women. Early initiation of remdesivir in pregnancy in the viremic phase seems to provide some advantages in the survival outcome. Its use may be associated with transient elevation in hepatic transaminases in some cases. No detrimental effects on the ongoing pregnancies, fetuses, or neonates have been observed. Further large-scale studies may provide more conclusive evidence.

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          Most cited references25

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          Remdesivir for the Treatment of Covid-19 — Final Report

          Abstract Background Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious. Methods We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. Results A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%). Conclusions Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.)
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            Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results

            Abstract Background World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs — remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a — in patients hospitalized with coronavirus disease 2019 (Covid-19). Methods We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. Results At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. Conclusions These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.)
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              A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics

              Although several experimental therapeutics for Ebola virus disease (EVD) have been developed, the safety and efficacy of the most promising therapies need to be assessed in the context of a randomized, controlled trial.
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                Author and article information

                Journal
                Cureus
                Cureus
                2168-8184
                Cureus
                Cureus (Palo Alto (CA) )
                2168-8184
                17 August 2023
                August 2023
                : 15
                : 8
                : e43671
                Affiliations
                [1 ] Obstetrics and Gynecology, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, Faridabad, IND
                [2 ] Pediatrics, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, Faridabad, IND
                [3 ] Anesthesiology, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, Faridabad, IND
                [4 ] Physiology and Molecular Biology, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, Faridabad, IND
                Author notes
                Article
                10.7759/cureus.43671
                10506363
                37727185
                0e7e4e51-d528-4502-9aaa-38284898718f
                Copyright © 2023, Sharma et al.

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 11 August 2023
                Categories
                Obstetrics/Gynecology
                Pulmonology
                Epidemiology/Public Health

                sars-cov-2,prone positioning,tocilizumab,covid-19,pregnancy,remdesivir

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