Covid 19CONNAITRENCT04384614
Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study
An observational study of Covid 19 and BCG Vaccination, run by Direction des Soins de Santé de Base at 1 site in Tunisia.
Trial summary
Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid 19, BCG Vaccination
- What is being tested?
- Test PCR, TDR and Clinical Examination
- How many people
- 0 participants
- Where
- 1 siteTunisia
- Study dates
- 15 May 2020to 15 Jul 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 400 Patients will be included between COVID19 (+) and COVID19 (-) patients who have been in contact with COVID19 (+)
Who may be able to join
- COVID-19 (+), inpatient or outpatient, confirmed by PCR test
- COVID-19 (-) confirmed by PCR test having been in contact with COVID-19 (+)
Who cannot join
- COVID(+) and COVID(-) diagnosed by other tests than PCR
- COVID-19 (-) Not having been in contact with COVID19(+)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study Multicentric Study
Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study
- Conditions
- Covid 19, BCG Vaccination
- Being tested
- Test PCR, TDR, Clinical Examination
- Keywords
- covid 19, BCG Vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test PCRDiagnostic test
Viral load (COVID+) testing by PCR
TDRGenetic
IDR and blood sampling for testing DNA Cheque
Clinical ExaminationOther
COVID 19 symptoms and Physical Examination
| Study group | Role | What they receive |
|---|---|---|
| COVID (+) | Patients COVID19(+) confirmed by PCR Receives: Diagnostic Test: Test PCR; Genetic: TDR; Other: Clinical Examination | |
| COVID (-) | Patients COVID19 (-) who had been in contact with COVID-19 (+) confirmed by PCR Receives: Diagnostic Test: Test PCR; Genetic: TDR; Other: Clinical Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 May 2020 (estimated)
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Why it stopped: The sponsor decided to withdraw the study for funding reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Direction des Soins de Santé de Base
- Sponsor type
- Other government
- Collaborators
- Eshmoun Clinical Research Center, Dacima Consulting
- Responsible party
- Principal investigator, Agnès Hamzaoui, Abderrahmane Mami Hospital
- Investigators
- Agnès Hamzaoui, Pr, Principal investigator, Hopital Abderrahmane Mami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384614
- Sponsor's protocol ID
- ECC2020-07
- Acronym
- CONNAITRE
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 In Tunisia: An Observational Cross-Sectional Registry Study Multicentric Study
- ClinicalTrials.gov ID
- NCT04384614
- Acronym / sponsor ID
- CONNAITRE / ECC2020-07
- Conditions
- Covid 19, BCG Vaccination
- Keywords
- covid 19, BCG Vaccination
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor decided to withdraw the study for funding reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Direction des Soins de Santé de BaseOther government
- Collaborators
- Eshmoun Clinical Research Center, Dacima Consulting
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Covid-19 In Tunisia: AN Observational Cross-Sectional Registry Study
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID (+) | – | Diagnostic Test: Test PCR, Genetic: TDR, Other: Clinical ExaminationPatients COVID19(+) confirmed by PCR |
| COVID (-) | – | Diagnostic Test: Test PCR, Genetic: TDR, Other: Clinical ExaminationPatients COVID19 (-) who had been in contact with COVID-19 (+) confirmed by PCR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 Patients will be included between COVID19 (+) and COVID19 (-) patients who have been in contact with COVID19 (+)
Key inclusion criteria (2 listed)
- COVID-19 (+), inpatient or outpatient, confirmed by PCR test
- COVID-19 (-) confirmed by PCR test having been in contact with COVID-19 (+)
Key exclusion criteria (2 listed)
- COVID(+) and COVID(-) diagnosed by other tests than PCR
- COVID-19 (-) Not having been in contact with COVID19(+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test PCRViral load (COVID+) testing by PCR | Diagnostic test | COVID (+), COVID (-) |
| TDRIDR and blood sampling for testing DNA Cheque | Genetic | COVID (+), COVID (-) |
| Clinical ExaminationCOVID 19 symptoms and Physical Examination | Other | COVID (+), COVID (-) |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnès Hamzaoui, Pr principal investigator
Hopital Abderrahmane Mami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid 19 and BCG Vaccination, run by Direction des Soins de Santé de Base at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences related to epidemiological demographic characteristics (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.