Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy and Postpartum

Summary

It still unclear how SARS-CoV-2 affects pregnant women and their offspring, as well as which factors may influence obstetrical disease and outcomes, including the timing of maternal viral exposure by gestational age, the effects of parity, age, host immune responses, coexisting medical and obstetrical conditions and the effects of treatment regimens. While further information is gathered, based on the existing evidence from other infections causing pneumonia, pregnant women should be considered to be at high risk for developing severe infection during the current COVID-19 epidemic. Results from clinical trials with HCQ in nonpregnant adults may not be directly extrapolated to pregnant women given the special features of the pregnancy status. Thus, clinical research is urgently needed to improve the care and reduce the risk of poor pregnancy outcomes of women in this and in future epidemics.

Timeline

Start

2020-05-13

Primary completion

2021-06-30

Completion

2021-10-31

Publications

• Gonzalez R, Gonce A, Gil MDM, 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 H, Bardaji A, Quinto L, Menendez C; COVID-Preg research group. 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. Acta Obstet Gynecol Scand. 2024 Mar;103(3):602-610. doi: 10.1111/aogs.14745. Epub 2023 Dec 14.
• Gonzalez R, Garcia-Otero L, Pons-Duran C, Marban-Castro E, Gonce A, Llurba E, Gil MDM, Rodriguez-Zambrano MA, Chen H, Ramirez M, Bardaji A, Menendez C. Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial. Trials. 2020 Jul 2;21(1):607. doi: 10.1186/s13063-020-04557-y.

Drugs

Indications