Important Data on COVID-19 Profile in Africa (AIDCO)

The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Africa

Detailed Description

In this study ,the participants will be enrolled sequentially in the COVID-19 care referral centers. The infected hospitalized patient will be identified by the physicians in hospital. After the patient has given his/her informed consent the permission will be sought from him to approach his household contacts. The household contacts will be screened, and included in the study.

Patients hospitalized and positive for COVID-19 by PCR and their household contacts of all ages and gender (40% minimum of female), will be enrolled upon receipt of written informed consent.

• Study Type: Observational
• Enrollment (Actual): 574

Contacts and Locations

Study Locations

• Gabon
  • Lambaréne, Gabon
    • Centre de Recherches Médicales de Lambréné
  • Moyen- Ogooué
    • Lambaréné, Moyen- Ogooué, Gabon, 1437
      • Centre de Recherches Médicales de Lammbaréné

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of volunteer COVID-19 patients hospitalized in referral center for COVID-19 care as well as the household contacts of these hospitalized COVID-19 patients in Gabon, Senegal and Ethiopia.

Description

Inclusion Criteria:

• Molecular (PCR) confirmed COVID-19 patients hospitalized in referral centers,
• Household contacts of hospitalized COVID-19 patient,
• Provided signed informed consent.

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Index cases; Patients infected by SARS-Cov2 Polymerase Chain Reaction (PCR) and hospitalized in a referral center for COVID-19 .
Households cases; Household contacts of SARS-Cov2 hospitalized COVID-19 patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical and biological parameters of COVID-19	Infection and disease progression - Pattern of virus transmission	14 days
SARS-CoV-2 transmissibility	proportion of household contact who will become positive for SARS-COV2 using PCR	14 days

Collaborators and Investigators

• Sponsor: Centre de Recherche Médicale de Lambaréné
• Collaborators: Leiden University Medical Center; European and Developing Countries Clinical Trials Partnership (EDCTP); Universität Tübingen; Institut de recherche en santé de surveillance épidémiologique et de formation; Université des Sciences de la Santé; Armauer Hansen Research Institute, Ethiopia
• Investigators: Principal Investigator: Ayôla Akim ADEGNIKA, Centre de Recherches Medicales de Lambarene; Principal Investigator: Marielle BOUYOU-AKOTET, Université des Sciences de Santé

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Coronavirus infection; Africa; Transmission; SARS-CoV
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 0011/2020/PR/SG/CNE; CEI-10/2020 (Other Identifier: Comité d'Ethique Institutionnel)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Results from our COVID-19 AFRICA, AIDCO, project will be published in peer reviewed journals, seeking rapid and open access publication. This will be done as fast and widely as possible. Results will also be submitted and presented in any national, regional and international scientific meetings and congresses dedicated to COVID-19 online or face to face if, permitted. Before submission for publication or presentation, the review process outlined in the Consortium Agreement and agreed upon by all partners will be followed and care will be taken with respect to intellectual property protection.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)