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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04410562
Other study ID # 2020-001587-29
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 13, 2020
Est. completion date October 31, 2021

Study information

Verified date April 2021
Source Barcelona Institute for Global Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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- 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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date October 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Presenting with fever (=37.5ÂșC) 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)

Study Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
Spain Hospital Universitario Fundación Alcorcón Alcorcón Madrid
Spain Hospital Clínic de Barcelona Barcelona Catalunya
Spain Hospital de la Sant Creu i Sant Pau Barcelona Catalunya
Spain Hospital del Mar Barcelona Catalunya
Spain Hospital Sant Joan de Déu Esplugues De Llobregat Catalunya
Spain Hospital Universitario Infanta Leonor Madrid
Spain HM Puerta del Sur Móstoles Madrid
Spain Hospital General de Segovia Segovia Cartilla Y León
Spain Hospital Universitario de Torrejón Torrejón De Ardoz Madrid

Sponsors (11)

Lead Sponsor Collaborator
Barcelona Institute for Global Health 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

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of PCR confirmed cases among pregnant women Number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start 21 days after intervention
Secondary Incidence of COVID-19 disease during pregnancy through study completion, an average of 1 year
Secondary Incidence of COVID-19-related admissions through study completion, an average of 1 year
Secondary Incidence of all-cause admissions through study completion, an average of 1 year
Secondary Incidence of all-cause outpatient attendances through study completion, an average of 1 year
Secondary Mean duration of symptoms-signs of COVID-19 through study completion, an average of 1 year
Secondary Frequency and severity of adverse events through study completion, an average of 1 year
Secondary Incidence of preeclampsia through study completion, an average of 1 year
Secondary Incidence of gestational diabetes through study completion, an average of 1 year
Secondary Incidence of SARS-CoV-2 infections during pregnancy through study completion, an average of 1 year
Secondary Prevalence of intrauterine growth restriction through study completion, an average of 1 year
Secondary Maternal mortality rate through study completion, an average of 1 year
Secondary Proportion of neonates with SARS-CoV-2- intrauterine infection by PCR-confirmed SARS-CoV-2-infection in nasopharyngeal aspirate. through study completion, an average of 1 year
Secondary Proportion of neonates with clinical signs/symptoms of COVID-19 through study completion, an average of 1 year
Secondary Prevalence of low birth weight (<10th centile according to local standards) through study completion, an average of 1 year
Secondary Prevalence of preterm birth (<37 weeks of gestational age) through study completion, an average of 1 year
Secondary Prevalence of embryo and foetal losses (miscarriages and stillbirths) through study completion, an average of 1 year
Secondary Frequency of congenital malformations through study completion, an average of 1 year
Secondary Proportion of adverse perinatal outcome through study completion, an average of 1 year
Secondary Neonatal morbidity through study completion, an average of 1 year
Secondary Neonatal mortality rate through study completion, an average of 1 year
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