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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04847817
Other study ID # 0011/2020/PR/SG/CNE
Secondary ID CEI-10/2020
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date March 1, 2022

Study information

Verified date April 2021
Source Centre de Recherche Médicale de Lambaréné
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 574
Est. completion date March 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Locations

Country Name City State
Gabon Centre de Recherches Médicales de Lambréné Lambaréne
Gabon Centre de Recherches Médicales de Lammbaréné Lambaréné Moyen- Ogooué

Sponsors (7)

Lead Sponsor Collaborator
Centre de Recherche Médicale de Lambaréné Armauer Hansen Research Institute, Ethiopia, European and Developing Countries Clinical Trials Partnership (EDCTP), Institut de recherche en santé de surveillance épidémiologique et de formation, Leiden University Medical Center, Universität Tübingen, Université des Sciences de la Santé

Country where clinical trial is conducted

Gabon, 

Outcome

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