Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT04345861
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised in the 96 h before randomization
* Beginning of COVID-19 symptoms \< 10 days at the time of randomization
* Presence of symptom(s) of COVID-19 : fever (température \> or = 37,5°C) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia
* Presence of TDM/radiographic signs or pneumonia
* Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy)
Exclusion Criteria:
* Absence of signed informed consent
* SpO2 \< 90 % ambient air or \< 94 % with oxygenotherapy \> or = 3l/min
* Need of oxygenotherapy \> 6 l/min or mechanical ventilation
* Need of hospitalization in ICU
* ALAT/ASAT \> 5 LSN
* Renal failure (eGFR \< 40 ml/min ) or dialysis
* Pregnancy or breastfeeding
* Retinopathy
* Known deficit in G6PD
* Cardiac rythm / lengthening QT disorders
* QT space lengthening on ECG with QTc \> 450 ms
* Concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine, anti-arhythmic class IA \& III, antidepressive drugs,..
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04345861
Study Brief:
Protocol Section:
NCT04345861