Efficacy and safety of hydroxychloroquine for treatment of mild SARS-CoV-2 infection and prevention of COVID-19 severity in pregnant and postpartum women: A randomized, double-blind, placebo-controlled trial
Por:
Gonzalez, R, Gonce, A, Gil, MD, Mazarico, E, Ferriols-Perez, E, Toro, P, Llurba, E, Saez, E, Rodriguez-Zambrano, MA, Garcia-Otero, L, Lopez, M, Santacruz, B, Roman, MA, Paya, A, Alonso, S, Cruz-Lemini, M, Pons-Duran, C, Herrera, LB, Chen, HLY, Bardaji, A, Quinto, L, Menendez, C
Publicada:
1 mar 2024
Ahead of Print:
1 dic 2023
Resumen:
Introduction: Pregnant women have an increased risk of severe COVID-19. Evaluation of drugs with a safety reproductive toxicity profile is a priority. At the beginning of the pandemic, hydroxychloroquine (HCQ) was recommended for COVID-19 treatment.Material and methods: A randomized, double-blind, placebo-controlled clinical trial was conducted in eight teaching hospitals in Spain to evaluate the safety and efficacy of HCQ in reducing viral shedding and preventing COVID-19 progression. Pregnant and postpartum women with a positive SARS-CoV-2 PCR (with or without mild COVID-19 signs/symptoms) and a normal electrocardiogram were randomized to receive either HCQ orally (400 mg/day for 3 days and 200 mg/day for 11 days) or placebo. PCR and electrocardiogram were repeated at day 21 after treatment start. Enrollment was stopped before reaching the target sample due to low recruitment rate. Trial registration EudraCT #: 2020-001587-29, on April 2, 2020. Clinical # NCT04410562, registered on June 1, 2020.Results: A total of 116 women (75 pregnant and 41 post-partum) were enrolled from May 2020 to June 2021. The proportion of women with a positive SARS-CoV-2 PCR at day 21 was lower in the HCQ group (21.8%, 12/55) than in the placebo group (31.6%, 18/57), although the difference was not statistically significant (P = 0.499). No differences were observed in COVID-19 progression, adverse events, median change in QTc, hospital admissions, preeclampsia or poor pregnancy and perinatal outcomes between groups.Conclusions: HCQ was found to be safe in pregnant and postpartum women with asymptomatic or mild SARS-CoV-2 infection. Although the prevalence of infection was decreased in the HCQ group, the statistical power was insufficient to confirm the potential beneficial effect of HCQ for COVID-19 treatment.
Filiaciones:
Gonzalez, R:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Consorcio Invest Biomed Red Epidemiol & Salud Publ, Madrid, Spain
Manhica Hlth Res Ctr CISM, Manhica, Mozambique
Univ Barcelona, Hosp Clin, Barcelona Inst Global Hlth ISGlobal, Maternal Child & Reprod Hlth Initiat, Rossello 132, Barcelona 08036, Spain
Gonce, A:
Univ Barcelona, Hosp Clin Barcelona, BCNatal Barcelona Ctr Maternal Fetal & Neonatal Me, Barcelona, Spain
Gil, MD:
Hosp Univ Torrejon, Obstet & Gynecol Dept, Madrid, Spain
Univ Francisco de Vitoria, Sch Med, Madrid, Spain
Mazarico, E:
Univ Barcelona, Hosp St Joan de Deu, BCNatal Barcelona Ctr Maternal Fetal & Neonatal Me, Barcelona, Spain
Univ Barcelona, Hosp Clin, Barcelona, Spain
Ferriols-Perez, E:
Hosp del Mar, Obstet & Gynecol Dept, Barcelona, Spain
Toro, P:
Hosp Gen Segovia, Obstet & Gynecol Dept, Segovia, Spain
Llurba, E:
Hosp Santa Creu & Sant Pau, Inst Invest Biomed St Pau IIB St Pau, Dept Obstet & Gynecol, Women & Perinatal Hlth Res Grp, Barcelona, Spain
Saez, E:
Hosp Univ Infanta Leonor, Obstet & Gynecol Dept, Madrid, Spain
Rodriguez-Zambrano, MA:
Hosp Univ Infanta Leonor, Obstet & Gynecol Dept, Madrid, Spain
Garcia-Otero, L:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Lopez, M:
Univ Barcelona, Hosp Clin Barcelona, BCNatal Barcelona Ctr Maternal Fetal & Neonatal Me, Barcelona, Spain
Santacruz, B:
Hosp Univ Torrejon, Obstet & Gynecol Dept, Madrid, Spain
Univ Francisco de Vitoria, Sch Med, Madrid, Spain
Roman, MA:
Univ Barcelona, Hosp St Joan de Deu, BCNatal Barcelona Ctr Maternal Fetal & Neonatal Me, Barcelona, Spain
Paya, A:
Hosp del Mar, Obstet & Gynecol Dept, Barcelona, Spain
Alonso, S:
Hosp Gen Segovia, Obstet & Gynecol Dept, Segovia, Spain
Cruz-Lemini, M:
Hosp Santa Creu & Sant Pau, Inst Invest Biomed St Pau IIB St Pau, Dept Obstet & Gynecol, Women & Perinatal Hlth Res Grp, Barcelona, Spain
Pons-Duran, C:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Herrera, LB:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Chen, HLY:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Consorcio Invest Biomed Red Epidemiol & Salud Publ, Madrid, Spain
Bardaji, A:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Consorcio Invest Biomed Red Epidemiol & Salud Publ, Madrid, Spain
Manhica Hlth Res Ctr CISM, Manhica, Mozambique
Quinto, L:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Consorcio Invest Biomed Red Epidemiol & Salud Publ, Madrid, Spain
Manhica Hlth Res Ctr CISM, Manhica, Mozambique
Menendez, C:
Univ Barcelona, Hosp Clin, ISGlobal, Barcelona, Spain
Consorcio Invest Biomed Red Epidemiol & Salud Publ, Madrid, Spain
Manhica Hlth Res Ctr CISM, Manhica, Mozambique
HM Puerta del Sur, Obstet & Gynecol Dept, Madrid, Spain
HM Puerta del Sur, Obstet & Gynecol Dept, Madrid, Spain
hybrid, All Open Access; Hybrid Gold Open Access
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