We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445441
Recruitment Status : Completed
First Posted : June 24, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Muraz

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Coronavirus Infection

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 24, 2020
Actual Primary Completion Date : September 3, 2020
Actual Study Completion Date : November 30, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Clearance of viral load [ Time Frame: 14 days ]
    The impact of the treatment on virological clearance (viral load) post-treatment


Secondary Outcome Measures :
  1. Safety of the treatment [ Time Frame: 14 days ]
    This outcome will include the occurrence of adverse events including significant changes in the relevant biological parameters


Biospecimen Retention:   Samples With DNA
nasopharyngeal swab

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- Any covid patient over 18 years treated according to standard of care
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445441


Locations
Layout table for location information
Burkina Faso
Sourou Sanon University Hospital
Bobo-Dioulasso, Burkina Faso, 01
Tingadogo University Hospital
Ouagadougou, Burkina Faso, 15
Sponsors and Collaborators
Centre Muraz
Investigators
Layout table for investigator information
Principal Investigator: Halidou Tinto, PhD IRSS - URCN
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Muraz
ClinicalTrials.gov Identifier: NCT04445441    
Other Study ID Numbers: IRSS-URCN-CM 001
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases