NCT04847817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
574

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

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

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 19, 2022

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

October 16, 2020

Last Update Submit

July 18, 2022

Conditions

Keywords

Coronavirus infectionSARS-CoVCOVID-19TransmissionAfrica

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Recherches Médicales de Lammbaréné

Lambaréné, Moyen-Ogooué Province, 1437, Gabon

Location

Centre de Recherches Médicales de Lambréné

Lambaréne, Gabon

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal mucosal Blood Urine Stool

MeSH Terms

Conditions

Coronavirus InfectionsSevere Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

  • Ayôla Akim ADEGNIKA

    Centre de Recherches Médicales de Lambaréné

    PRINCIPAL INVESTIGATOR
  • Marielle BOUYOU-AKOTET

    Université des Sciences de Santé

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 16, 2020

First Posted

April 19, 2021

Study Start

August 1, 2020

Primary Completion

December 31, 2021

Study Completion

March 1, 2022

Last Updated

July 19, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2 years

Locations