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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04390594
Eligibility Criteria:
Inclusion Criteria:
* Confirmed cases of SARS-CoV-2 infection hospitalized in reference services identified by the Ministry of Health and Social Action of Senegal
* Adults (≥18 years)
* Full understanding and consent to participate to the trial
* No contraindications to taking the tested treatments
* Clinical status from 3 to 5 on the seven-category ordinal scale
* Pneumonia highlighted by infiltration of the lungs by chest CT scan or chest radiography
* Absence of contraindications to radiographic examinations (X-ray and/or CT scan) for diagnosis and/or follow-up
* Inclusion in the 72 hours following the radiological pneumonia confirmation
Non-inclusion Criteria:
* Pregnant or breastfeeding woman
* Patient at high risk of death within 3 days of inclusion, in the clinician's opinion
* Corrected QT interval (QTc) \>500ms
* Heart electrical dysfunction: atrioventricular block Mobitz type II second-degree, high-grade or complete without a functioning pacemaker
* Uncontrolled and clinically significant heart diseases, such as arrhythmia, angina or decompensated congestive heart failure
* Kidney failure (Cl \< 30 mL/min)
* Patients with liver cirrhosis whose Child-Puch score is B or C
* Patients who have liver disease abnormalities with ALT or AST \> 5 times ULN
* Patients who have a known HIV status
* Patients who have other clinically-important diseases in decompensation which may interfere with the evaluation or completion of the tested treatment's procedure, in the clinician's opinion
* Patients with a clinical or psychological condition which, in the clinician's opinion, does not allow adequate evaluation of the tested treatment
* Known allergy to the studied treatment regimen
* Other contraindications with the studied treatment regimen
* Known drug-drug interaction with a treatment usually taken by the participant contraindicating one of the studied treatment regimen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04390594
Study Brief:
Protocol Section:
NCT04390594