Status:
TERMINATED
Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal
Lead Sponsor:
Institut Pasteur de Dakar
Collaborating Sponsors:
Fann Hospital, Senegal
Ministry of Health, Senegal
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019....
Detailed Description
COVID-19 is an emerging pandemic disease affecting most countries including Senegal, caused by the new coronavirus (SARS-CoV-2) which was first detected in the city of Wuhan in China in December 2019....
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04390594
Start Date
August 13 2020
End Date
February 8 2023
Last Update
June 21 2024
Active Locations (3)
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1
Infectious and Tropical Diseases Department, Fann Hospital
Dakar, Senegal
2
Diamniadio Children Hospital
Diamniadio, Senegal
3
Dalal Jamm Hospital
Guédiawaye, Senegal