SARS-SoV-2 infection and CoVid-19 disease MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Sponsors
Barcelona Institute for Global Health (ISGlobal)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the effect of HCQ in reducing maternal viral load 2. To asses the efficacy of HCQ to prevent incident SARS-CoV-2 infection;Secondary Objective: 1. To determine the impact of HCQ on the clinical course and duration of the COVID-19 disease 2. To evaluate the effect of HCQ in avoiding the development of the COVID-19 disease in asymptomatic-infected women 3. To determine the safety and tolerability of HCQ in pregnant women 4. To describe the clinical presentation of SARS-CoV-2 and the effects on pregnancy outcomes 5. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2;Primary end point(s): - The mean reduction in viral load at day 14 after recruitment among those women infected by SARS-CoV-2, in the ITT and ATP cohorts, adjusted by age, gravidity, region(municipality) and other variables associated with the prevalence and viral load of SARS-CoV-2 infection. - The comparison of the proportion of pregnant women who were close contacts of confirmed cases of SARS-CoV-2 infection, with a positive PCR for the infection at day 14, in the ITT and ATP cohorts, adjusted by adjusted by age, gravidity, region(municipality) and other variables associated with the prevalence of SARS-CoV-2 infection.;Timepoint(s) of evaluation of this end point: Day 14 after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean duration of CoVid-19 disease - Severity of CoVid-19 disease - Adverse effects of hydroxychloroquine - Frequency and severity of adverse events - Incidence of all-cause hospital admissions - Mean haemoglobin concentration at delivery - Maternal mortality rate - Mean birth weight - Mean gestational age at birth - Prevalence of prematurity - Prevalence of embryo and foetal losses (miscarriages and stillbirths) - Prevalence of small for gestational age - Frequency of congenital malformations - Neonatal mortality rate - Frequency of mother to child transmission of SARS-CoV-2;Timepoint(s) of evaluation of this end point: At delivery | — |
Countries
Spain
Contacts
Public ContactClara Menéndez
Barcelona Institute for Global Health (ISGlobal)
Outcome results
None listed