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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384614
Recruitment Status : Withdrawn (The sponsor decided to withdraw the study for funding reasons.)
First Posted : May 12, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
Eshmoun Clinical Research Centre
Dacima Consulting
Information provided by (Responsible Party):
Agnès Hamzaoui, Abderrahmane Mami Hospital

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

Condition or disease Intervention/treatment
Covid 19 BCG Vaccination Diagnostic Test: Test PCR Genetic: TDR Other: Clinical Examination

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Month
Official Title: Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study Multicentric Study
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
  • DNA Check
  • TDR


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
400 Patients will be included between COVID19 (+) and COVID19 (-) patients who have been in contact with COVID19 (+)
Criteria

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(+)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384614


Locations
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Tunisia
Eshmoun Clinical Research Centre
Tunis, Tunisia
Sponsors and Collaborators
Direction des Soins de Santé de Base
Eshmoun Clinical Research Centre
Dacima Consulting
Investigators
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Principal Investigator: Agnès Hamzaoui, Pr Hopital Abderrahmane Mami
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Responsible Party: Agnès Hamzaoui, Head of department, Abderrahmane Mami Hospital
ClinicalTrials.gov Identifier: NCT04384614    
Other Study ID Numbers: ECC2020-07
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agnès Hamzaoui, Abderrahmane Mami Hospital:
covid 19
BCG Vaccination