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.
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- pregnant women and 514 SARS-CoV-2 uninfected pregnant women who are contacts
with a SARS-CoV-2 case) with the main objectives of assessing the safety and efficacy of oral
hydroxychloroquine (HCQ) in reducing maternal viral shedding by PCR, and preventing incident
SARS-CoV-2 infection and disease severity. Pregnant women undergoing antenatal follow up at
five maternity hospitals, presenting at least one sign and/or one mild suggestive symptoms
and a positive SARS-CoV-2 PCR test, or who are contacts of a suspected or confirmed case,
will be recruited and randomized 1:1 to receive HCQ orally (400 mg/day for 3 days, followed
by 200 mg/day for 11 days) or placebo. Women will be followed up for the duration of the
intervention. One week after intervention completion, a SARS-CoV-2 PCR test will be repeated.
At delivery, the pregnancy outcome will be registered, and a cord blood sample will be
collected to measure for IgG and IgM of SARS-CoV-2. A neonatal nasopharyngeal aspirate will
be collected to perform PCR SARS-CoV-2 testing.
Drug: Hydroxychloroquine
Participants will receive a bottle containing 19 tablets of study medication. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days. (400 mg/day for three days, followed by 200 mg/day for 11 days).
Other Name: Dolquine
Drug: Placebo
Participants will receive a bottle containing 19 tablets of placebo. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days.
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)
Hospital General de Segovia
Segovia, Cartilla Y León, Spain
Hospital del Mar
Barcelona, Catalunya, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya, Spain
Hospital de la Sant Creu i Sant Pau
Barcelona, Catalunya, Spain
Hospital Sant Joan de Déu
Esplugues De Llobregat, Catalunya, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
HM Puerta del Sur
Móstoles, Madrid, Spain
Hospital Universitario de Torrejón
Torrejón De Ardoz, Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain