Status:
COMPLETED
Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy and Postpartum
Lead Sponsor:
Barcelona Institute for Global Health
Collaborating Sponsors:
Hospital Clinic of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Pregnancy Related
COVID
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a randomized, double blinded, placebo-controlled multicenter clinical trial including 714 pregnant women (200 SARS-CoV-2 infected -100 symptomatic with mild disease and 100 asymptomatic- pregn...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04410562
Start Date
May 13 2020
End Date
October 31 2021
Last Update
January 12 2022
Active Locations (9)
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1
Hospital General de Segovia
Segovia, Cartilla Y León, Spain, 40002
2
Hospital del Mar
Barcelona, Catalonia, Spain, 08003
3
Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain, 08036
4
Hospital de la Sant Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041