Can hydroxychloroquine (HCQ) safely prevent infection and severe complications in pregnant women? This study focues on prevent COVID-19 during pregnancy
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Global Health Institute Barcelona (ISGlobal) is an innovative alliance between academic, government, and philanthropic institutions to contribute to the efforts undertaken by the international community to address the challenges in global health and is the coordinator of this multicenter clinical trial.
Description of the Study:
- Title: COVID-Preg: Efficacy and Safety of Hydroxychloroquine in Preventing SARS-CoV-2 Infection and Severe COVID-19 Illness During Pregnancy.
- Principal Investigator: Edurne Mazarico Gallego and Clara Menéndez.
- Co-Investigators: Anna Goncé, Clara Pons, Elena Marbán, Azucena Bardají, Raquel González, Laura Garcia, Haily Chen and Máximo Ramírez.
- Centers of Implementation: SJD Barcelona Children’s Hospital, Hospital Clínic, Hospital Santa Creu i Sant Pau, Hospital del Mar, Hospital Universitario de Torrejón, HM Puerta del Sur, Hospital Infanta Leonor, Hospital de Alcorcón and Hospital General de Segovia.
- Study Population: Simple random sampling of 714 pregnant women for more than twelve weeks, who have had close contact with a confirmed or suspected case of COVID-19 in the last two weeks, or have had symptoms consistent with COVID-19 disease.
- Design: Randomized and placebo-controlled clinical trial.
- Method: A sample will be taken from the nasopharynx to perform a PCR test. The women in each group will be randomized to receive either hydroxycholoquine (HCQ) or a placebo.
Objectives of the Study:
Principal objectives: Evaluate the effect of HCQ in the following cases:
(1) To reduce viral shedding of SARS-CoV-2 in infected pregnant women with mild symptoms.
(2) To prevent SARS-CoV-2 infection in pregnant women who have been in contact with confirmed or suspected cases of COVID-19.
(3) To prevent the development of COVID-19 disease in asymptomatic pregnant women infected.
(1) To determine the effect of HCQ during COVID-19 disease in infected pregnant women.
(2) To determine the impact of HCQ on the risk of hospitalization and mortality in pregnant women infected with SARS-CoV-2.
(3) To evaluate the safety and tolerability of HCQ in pregnant women.
(4) To describe the clinical presentation, perinatal outcomes and the effects of maternal SARS-CoV-2 infection during pregnancy.
(5) To determine the risk of vertical transmission of SARS-CoV-2.
More about this Study:
Context: Knowledge of the consequences of COVID-19 in pregnant women is still limited, and developing severe disease may have significant implications. At the moment, only non-pharmacological measures are recommended to prevent SARS-CoV-2 infection. However, this study presents a new approach exploring whether HCQ can safely prevent COVID-19 during pregnancy.
Sant Joan de Déu: It is a university hospital specializing in the fields of pediatrics, gynecology, and obstetrics, which has a long history of more than 150 years, during which it has undergone many transformations and changes due to the need to adapt both to the social and health conditions of the time and to technological advances and the evolution of health care.
Kids Corona: The Kids Corona platform, which the San Joan de Déu Hospital launched last April continues to offer answers to better understand the incidence, impact, and transmission capacity of COVID-19 in children and pregnant women. In other words, the platform gathers different Pediatrics studies related to COVID-19 to improve the treatment, outcome, and transmission, for instance at school such as in this study, of the pediatric population.
Other Kids Corona Projects:“Susceptibility to COVID-19 in pediatric age: Study of cases and household contacts“, “SARS-CoV-2 seroconversion during the postoperative period in pediatric patients“, “Susceptibility to COVID-19 in pediatric age: Study of cases in school-like environments“, “Characterization of COVID-19 in the Pediatric Population: Study of Sero-surveillance and of Immunological and Biochemical Biomarkers of Disease Severity” and “Identifying SARS-CoV-2 in breast milk as a potential means of vertical transmission“.