Hydroxychloroquine efficacy in preventing SARS-CoV-2 infection and CoVid-19 disease severity during pregnancy

Barcelona Institute for Global Health (ISGlobal)0 个研究点目标入组 714 人开始时间: 2020年4月13日最近更新: 2020年4月20日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Barcelona Institute for Global Health (ISGlobal)