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

NCT04384614 | Withdrawn

• 1 other identifier: ECC2020-07
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid 19; BCG Vaccination

Keywords

covid 19; BCG Vaccination

Outcome Measures

Primary Outcomes (1)

• Differences related to epidemiological demographic characteristics

  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

Study Arms (2)

COVID (+)

Patients COVID19(+) confirmed by PCR

Diagnostic Test: Test PCR; Genetic: TDR; Other: Clinical Examination

COVID (-)

Patients COVID19 (-) who had been in contact with COVID-19 (+) confirmed by PCR

Diagnostic Test: Test PCR; Genetic: TDR; Other: Clinical Examination

Interventions

Test PCR DIAGNOSTIC_TEST

Viral load (COVID+) testing by PCR

COVID (+); COVID (-)

TDR GENETIC

IDR and blood sampling for testing DNA Cheque

COVID (+); COVID (-)

Clinical Examination OTHER

COVID 19 symptoms and Physical Examination

COVID (+); COVID (-)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Direction des Soins de Santé de Base: lead
• Eshmoun Clinical Research Center: collaborator
• Dacima Consulting: collaborator

Study Sites (1)

Eshmoun Clinical Research Centre

Tunis, Tunisia

Location

Biospecimen

Retention: SAMPLES WITH DNA

* DNA Check * TDR

MeSH Terms

Conditions

COVID-19

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Agnès Hamzaoui, Pr

  Hopital Abderrahmane Mami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 12, 2020
• Study Start: May 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)