Preventing SARS-CoV-2 virus infection and severity of COVID-19 diseases during pregnancy with hydroxychloroquine

Phase 1

• Conditions: SARS-SoV-2 infection and CoVid-19 disease; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001587-29-ES
• Lead Sponsor: Barcelona Institute for Global Health (ISGlobal)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-13
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 714

Inclusion Criteria

Pregnant women of any gestational age, parity and age, who are undergoing routinely pre-natal follow up at the recruitment hospitals, with or without symptoms/signs suggestive of SARS-CoV-2 infection.
After a PCR to confirm or discard SARS-CoV-2 infection, and an electrocardiogram (ECG) to rule out any arrhythmia are done, women will be included in one of the following groups:

a)Pregnant women of any gestational age, parity and age, who are undergoing routinely pre-natal follow up at the recruitment hospitals, with a polymerase chain reaction (PCR)-confirmed SARS-CoV-2 diagnosis, with mild or without symptoms/signs suggestive of the infection.
b)Pregnant women of any gestational age, parity and age, who are undergoing routinely pre-natal followed up at the recruitment hospitals, with a negative PCR- SARS-CoV-2 who are contacts (at the household level) of a confirmed or clinically suspected case of the infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 714
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known hypersensitivity to HCQ or other 4-amonoquinoline compounds, history of retinopathy of any etiology, concomitant use of digoxin, cyclosporine, cimetidine or tamoxifen, known liver disease, clinical history or with ECG findings suggestive of cardiac pathology. In addition, those women that are unable to cooperate with the requirements of the study will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified