COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001587-29/ES

Barcelona Institute for Global Health (ISGlobal) - Clara Menéndez

clara.menendez@isglobal.org

2020-04-13

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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. Mujeres embarazadas de cualquier edad gestational, paridad y edad, que estén en seguimiento rutinario prenatal en los hospitales del estudio, con o sin síntomas/signos sugestivos de infección por SARS-CoV-2. Después de realizar una PCR para confirmar o descartar infección por SARS-CoV-2, y un electrocardiograma para descartar posibles arritmias, las mujeres serán incluidas en uno de los siguientes grupos: a) Mujeres embarazadas de cualquier edad gestacional, paridad y edat, que estén en seguimiento rutinario prenatal en los hospitales del estudio, con un diagnóstico confirmado por PCR de infección por SARS-CoV-2, con síntomas/sginos leves o sin síntomas/signos sugestivos de infección b) Mujeres embarazadas de cualquier edad gestacional, paridad y edat, que estén en seguimiento rutinario prenatal en los hospitales del estudio, con una PCR negativa de SARS-CoV-2, que sean contactos (a nivel del hogar) de un caso confirmado o clínicamente sospechoso de infección

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. Historia conocida de hipersensibilidad a la HCQ o a otros compuestos 4-amonoquinolina, historia de retinopatía de cualquier etiología, uso concomitante de digoxina, ciclosporina, cimetidina o tamoxifen, enfermedad hepática conocida, historia clínica de enfermedad cardíaca o hallazgos sugestivos de patología cardiaca en el electrocardiograma. Además, aquellas mujeres que sean incapaces de llevar a cabo los requerimientos del estudio, van a ser excluidas.

4

Barcelona Institute for Global Health (ISGlobal)

18

64

Spain

Close contacts to covid patients

N/A

714

- 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. NA

Declared number of arm (7.0) differs from found arms (2.0)

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]