COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04390594

Fabien Taieb, MD, PhD

Fabien.taieb@pasteur.sn

2020-05-15

Unknown

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

None

2

Institut Pasteur de Dakar

18

None

Senegal

No restriction on type of patients

0: No restriction on type of patients

186

SARS-CoV-2 viral load level

None

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]