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

NCT ID: NCT04445441

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-24
• Study Completion Date: 2020-11-30

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.

Conditions

Coronavirus Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Muraz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Halidou Tinto, PhD

Role: PRINCIPAL_INVESTIGATOR

IRSS - URCN

Locations

Sourou Sanon University Hospital

Bobo-Dioulasso, , Burkina Faso

Tingadogo University Hospital

Ouagadougou, , Burkina Faso

Countries

Burkina Faso

Other Identifiers

IRSS-URCN-CM 001

Identifier Type: -

Identifier Source: org_study_id