COVID-19 STAndard of Care in Sub-Saharan Africa (COVISTA)

May 11, 2021 updated by: Alliance for International Medical Action

Observational Study of the Clinico-biological Evolution and the Standard of Care Offered to Symptomatic Covid-19 Patients in Sub-Saharan Africa

This study was conducted in three African countries on four COVID-19 care centers (CCCs). The CCCs were set up in collaboration with a medical NGO with long experience in recording and monitoring data for cohorts and clinical trials in emergency contexts. The data were recorded using the WHO COVID-19 rapid core case report form.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2495

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Ouagadougou, Burkina Faso, BP104
        • Chu Tengandogo
      • Ouagadougou, Burkina Faso, BP51145
        • Clinique Princesse Sarah
  • Guinea
      • Conakry, Guinea, BP834
        • CHU Donka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People hospitalized with symptomatic of COVID-19 and a positive RT-PCR SARS-CoV-2 test

Description

Inclusion Criteria:

  • SARS-CoV-2 positive at RT-PCR

Exclusion Criteria:

  • Asymptomatic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: During hospitalization, with an average of 11 days
In hospital mortality
During hospitalization, with an average of 11 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical worsening
Time Frame: Hospitalization, with an average of 11 days
Combination of an SpO2 <94% at least once during follow-up (including at baseline), use of oxygen therapy at any time during follow-up, or death
Hospitalization, with an average of 11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for International Medical Action

Investigators

  • Principal Investigator: Denis Malvy, Pr, CHU Bordeaux, INSERM 1219

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (ACTUAL)

May 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALIMA02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe