An Observational Study to Assess the Protocol for the COVID-19 Treatment in Burkina Faso

Completed

• Conditions: Coronavirus Infection

• Registration Number: NCT04445441
• Lead Sponsor: Centre Muraz

Brief Summary

This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.

Detailed Description

All patients who received one of the two combinations will be included in the study and followed-up until the patient is discharged from the hospital. They will be seen daily during the period of their active clinical follow-up at the hospital. At each visit, the medical history since the last visit (including treatments taken), signs and symptoms in progress if any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and then on day 21 if he is still positive in order to assess the evolution of the viral load. However if until the end of the follow-up on D21 the test is still positive, the sampling will be continued until the patient become negative as recommended by the national standard of care for the Covid patients management in Burkina Faso.

In terms of safety, an ECG will be performed on day 0 prior to the treatment administration and this will be repeated on day 7 and day 14 and every week until it normalizes or the patient will be recommended to see a cardiologist to check the normalization of his ECG after discharge from hospital. Adverse events will be recorded including biological parameters (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory parameters.

Study Timeline

• Study Start: 2020-04-24
• Status Verified: 2020-06
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Primary Completion: 2020-09-03
• Study Completion: 2020-11-30
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Any patient over 18 years treated according to the standard of care
• Willing to participate in the study by giving an informed consent

Exclusion Criteria

• Patients under 18 years of age
• Not willing to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clearance of viral load	14 days	The impact of the treatment on virological clearance (viral load) post-treatment

Secondary Outcome Measures

Name	Time	Method
Safety of the treatment	14 days	This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters

Trial Locations

Locations (2)

Tingadogo University Hospital; 🇧🇫 Ouagadougou, Burkina Faso

Sourou Sanon University Hospital; 🇧🇫 Bobo-Dioulasso, Burkina Faso