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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Barcelona Institute for Global Health
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Fundación de investigación HM; Hospital Clinic of Barcelona; Hospital del Mar; Hospital General de Segovia; Hospital Sant Joan de Deu; Hospital Universitario Fundación Alcorcón; Hospital Universitario Infanta Leonor; Institut Català de la Salut; University Hospital of Torrejon
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• Presenting with fever (≥37.5ºC) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, taste disorder, headache) OR contact of a SARS-CoV-2 confirmed or suspected case in the past 14 days

• More than 12 weeks of gestation (dated by ultrasonography)

• Agreement to deliver in the study hospitals

Exclusion Criteria:

• Known hypersensitivity to HCQ or other 4-aminoquinoline compounds

• History of retinopathy of any aetiology

• Concomitant use of digoxin, cyclosporine, cimetidine

• Known liver disease

• Clinical history of cardiac pathology including known long QT syndrome

• Unable to cooperate with the requirements of the study

• Participating in other intervention studies

• Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours)