NCT04445441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 22, 2021

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 22, 2020

Last Update Submit

January 21, 2021

Conditions

Coronavirus Infection

Outcome Measures

Primary Outcomes (1)

  • Clearance of viral load

    The impact of the treatment on virological clearance (viral load) post-treatment

    14 days

Secondary Outcomes (1)

  • Safety of the treatment

    14 days

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Any covid patient over 18 years treated according to standard of care

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sourou Sanon University Hospital

Bobo-Dioulasso, 01, Burkina Faso

Location

Tingadogo University Hospital

Ouagadougou, 15, Burkina Faso

Location

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swab

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Halidou Tinto, PhD

    IRSS - URCN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

April 24, 2020

Primary Completion

September 3, 2020

Study Completion

November 30, 2020

Last Updated

January 22, 2021

Record last verified: 2020-06

Locations

BU(2)