Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study (CONNAITRE)

August 25, 2020 updated by: Agnès Hamzaoui, Direction des Soins de Santé de Base

Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study Multicentric Study

Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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

  • Tunisia
      • Tunis, Tunisia
        • Eshmoun Clinical Research Centre

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

400 Patients will be included between COVID19 (+) and COVID19 (-) patients who have been in contact with COVID19 (+)

Description

Inclusion Criteria:

  • COVID-19 (+), inpatient or outpatient, confirmed by PCR test
  • COVID-19 (-) confirmed by PCR test having been in contact with COVID-19 (+)

Exclusion Criteria:

  • COVID(+) and COVID(-) diagnosed by other tests than PCR
  • COVID-19 (-) Not having been in contact with COVID19(+)

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID (+)
Patients COVID19(+) confirmed by PCR
Diagnostic test: Test PCR
Viral load (COVID+) testing by PCR
Genetic: TDR
IDR and blood sampling for testing DNA Cheque
Other: Clinical Examination
COVID 19 symptoms and Physical Examination
COVID (-)
Patients COVID19 (-) who had been in contact with COVID-19 (+) confirmed by PCR
Diagnostic test: Test PCR
Viral load (COVID+) testing by PCR
Genetic: TDR
IDR and blood sampling for testing DNA Cheque
Other: Clinical Examination
COVID 19 symptoms and Physical Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences related to epidemiological demographic characteristics
Time Frame: 30 days

Identify differences related to epidemiological demographic characteristics and the profile of COVID(+) vs. the profile of COVID(-) patients who have been in contact with COVID(+)

  • Vaccination History Questionnaire
  • Medical and Surgical History Questionnaire
  • Clinical Examination
  • TDR and blood sampling for DNA Checks
30 days

Collaborators and Investigators

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

Sponsor

Direction des Soins de Santé de Base

Collaborators

Dacima Consulting
Eshmoun Clinical Research Center

Investigators

  • Principal Investigator: Agnès Hamzaoui, Pr, Hopital Abderrahmane Mami

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 (Anticipated)

May 15, 2020

Primary Completion (Anticipated)

July 15, 2020

Study Completion (Anticipated)

July 15, 2020

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 9, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECC2020-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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