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
González, Raquel (Hospital Clínic i Provincial de Barcelona)
Goncé, Anna (Hospital Clínic i Provincial de Barcelona)
Gil, Mª del Mar (Universidad Francisco de Vitoria)
Mazarico, Edurne (Hospital Clínic i Provincial de Barcelona)
Ferriols Pérez, Elena (Hospital del Mar (Barcelona, Catalunya))
Toro, Paloma (Hospital General de Segovia)
Llurba, E (Institut d'Investigació Biomèdica Sant Pau)
Saéz, Elisa (Hospital Universitario Infanta Leonor)
Rodríguez-Zambrano, Miguel Ángel (HM Puerta del Sur)
García-Otero, Laura (Hospital Clínic i Provincial de Barcelona)
López, Marta (Hospital Clínic i Provincial de Barcelona)
Santacruz, Belén (Universidad Francisco de Vitoria)
Román, Mª Ángeles (Hospital Clínic i Provincial de Barcelona)
Payà, Antonio (Hospital del Mar (Barcelona, Catalunya))
Alonso, Sofia (Hospital General de Segovia)
Cruz-Lemini, Monica (Institut de Recerca Sant Pau)
Pons-Duran, Clara (Hospital Clínic i Provincial de Barcelona)
Herrera, Luis Bernardo (Hospital Clínic i Provincial de Barcelona)
Chen, Haily (Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública)
Bardají, Azucena (Manhiça Health Research Center (CISM))
Quintó, Llorenç (Manhiça Health Research Center (CISM))
Menendez, Clara (Manhiça Health Research Center (CISM))
Universitat Autònoma de Barcelona

Data:	2024
Resum:	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. 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 trials. gov # NCT04410562, registered on June 1, 2020. 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. 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	COVID-19 ; SARS-CoV-2 ; Hydroxychloroquine ; Pregnancy ; Randomized controlled trial ; Women
Publicat a:	Acta obstetricia et gynecologica Scandinavica, Vol. 103 Núm. 3 (march 2024) , p. 602-610, ISSN 1600-0412

DOI: 10.1111/aogs.14745
PMID: 38098221

9 p, 1.1 MB

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