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

Coronavirus Infection Clinical Trial

— CHLORAZ  

Official title:

An Observational Study to Assess the Effectiveness of the Standard of Care (Hydroxychloroquine+Azythromicin or Chloroquine+Azythromicin) Recommended by the Ministry of Health for the Treatment of the Coronavirus Infection in Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445441
• Other study ID #: IRSS-URCN-CM 001
• Status: Completed
• Start date: April 24, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: June 2020
• Source: Centre Muraz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 30, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Burkina Faso	Sourou Sanon University Hospital	Bobo-Dioulasso
Burkina Faso	Tingadogo University Hospital	Ouagadougou

Sponsors (1)

Lead Sponsor	Collaborator
Centre Muraz

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of viral load	The impact of the treatment on virological clearance (viral load) post-treatment	14 days
Secondary	Safety of the treatment	This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters	14 days