Clincosm LogoSign in Get a demo

COVISTA: COVID-19 STAndard of Care in Sub-Saharan Africa

Sponsor
Alliance for International Medical Action (Other)
Overall Status
Completed
CT.gov ID
NCT04885543
Collaborator
(none)
2,495
Enrollment
3
Locations
12
Actual Duration (Months)
831.7
Patients Per Site
69.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2495 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observational Study of the Clinico-biological Evolution and the Standard of Care Offered to Symptomatic Covid-19 Patients in Sub-Saharan Africa
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    Mar 1, 2021
    Actual Study Completion Date :
    Mar 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [During hospitalization, with an average of 11 days]

      In hospital mortality

    Secondary Outcome Measures

    1. Clinical worsening [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • SARS-CoV-2 positive at RT-PCR
    Exclusion Criteria:
    • Asymptomatic patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Tengandogo Ouagadougou Burkina Faso BP104
    2 Clinique Princesse Sarah Ouagadougou Burkina Faso BP51145
    3 Chu Donka Conakry Guinea BP834

    Sponsors and Collaborators

    • Alliance for International Medical Action

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alliance for International Medical Action
    ClinicalTrials.gov Identifier:
    NCT04885543
    Other Study ID Numbers:
    • ALIMA02
    First Posted:
    May 13, 2021
    Last Update Posted:
    May 13, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of May 13, 2021