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
Raquel González, Laura García-Otero, Clara Pons-Duran, Elena Marbán-Castro, Anna Goncé, Elisa Llurba, Maria Del Mar Gil, Miguel Ángel Rodríguez-Zambrano, Haily Chen, Máximo Ramírez, Azucena Bardají, Clara Menendez
Trials, doi:10.1186/s13063-020-04557-y
Objectives: The primary objectives of the study are: 1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms. 2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case. 3. To evaluate the effect of HCQ in preventing the development of the COVID-19 disease in asymptomatic SARS-CoV-2-infected pregnant women. The secondary objectives are: 1. To determine the effect of HCQ on the clinical course and duration of the COVID-19 disease in SARS-CoV-2-infected pregnant women. 2. To determine the impact of HCQ on the risk of hospitalization and mortality of SARS-CoV-2-infected pregnant women. 3. To assess the safety and tolerability of HCQ in pregnant women. 4. To describe the clinical presentation of SARS-CoV-2 infection during pregnancy. 5. To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group.
Numbers to be randomised (sample size): This study requires 200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm. Trial Status: Protocol version 1.0, from May 8 th , 2020. Recruitment is ongoing (first patient recruited the 19 th May 2020 and recruitment end anticipated by December 2020). Trial registration: EudraCT number: 2020-001587-29, registered 2 April 2020. Clinicaltrials.gov identifier: NCT04410562, retrospectively registered 1 June 2020. Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Keywords: COVID-19, Randomised controlled trial, Protocol, Hydroxychloroquine, Pregnant, Women
Supplementary information Supplementary information accompanies this paper at https://doi.org/10. 1186/s13063-020-04557-y.
Ethics approval and consent to participate On April 2 nd , 2020, a short trial proposal was approved by the Comité de Ética en Investigación of the Hospital Clínic of Barcelona to allow the start of the clinical trial procedures in the COVID-19 emergency situation (trial code HCB/2020/0382, meeting reference 9/2020_Extraordinària). The full trial protocol was approved as an amendment by the same committee on the ordinary meeting of May 14 th , 2020...
