COVID-19 DiseaseNCT05603130
Epidemiologic Register on Diabetes and COVID-19 in Tunisia
An observational study of COVID-19 Disease, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial summary
CoviDTUN is a multicenter observatory set up by a steering committee to determine the presentation and evolution of diabetes in COVID-19 and study its pathogenesis. The observatory comprises a dataset consisting of routinely collected clinical information anonymously to be entered by the investigator as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Disease
- What is being tested?
- routinely collected clinical information
- How many people
- 811 participants
- Where
- 1 siteTunisia
- Study dates
- 23 Mar 2022to 17 Oct 2022
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Confirmed COVID-19 patients, treated on an outpatient basis, in containment centers or hospitalized in COVID-19 units.
Who may be able to join
- Diagnosis of COVID-19 infection confirmed by an evocative clinical picture according to INEAS score or a positive polymerase chain reaction [PCR] test and/or chest CT specific radiological signs and/or a rapid diagnostic antigen test.
- Diabetes known before COVID-19 (known diabetes patient before COVID-19: Diabetic patient before COVID-19: History in medical record and/or presence of antidiabetic therapy and/or HbA1c ≥ 6.5%).
- or
- De novo diabetes (the de novo diabetic patient is defined as: Fasting blood glucose ≥ 1.26 g/L (7mmol/L) or postprandial blood glucose ≥ 2g/L (11.1 mmol/L) within 2 weeks of COVID-19 infection, no history of diabetes before the COVID-19 episode)).
Who cannot join
- children
- pregnant women
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Autoimmune diseases research unit UR17DN02, Department of Internal Medicine at the Military Hospital of Tunis
Tunis
About this study
Official title: Diabetes and COVID-19 in Tunisia (CoviDTUN)
CoviDTUN is a multicenter observatory set up by a steering committee to determine the presentation and evolution of diabetes in COVID-19 and study its pathogenesis.
The observatory comprises a dataset consisting of routinely collected clinical information anonymously to be entered by the investigator as a participating clinician/researcher.
The study will be an opportunity to understand the relationship between COVID-19 and diabetes, to enrich Tunisian data on diabetic and de novo diabetic patients who have contracted COVID-19 and to evaluate the prognostic severity factors for better management of these patients.
Read the detailed description
It is a multicentric Tunisian observatory for COVID-19 patients. Confirmed COVID-19 patients, treated on an outpatient basis, in containment centers or hospitalized in COVID-19 units were included retrospectively from March 2020 and had continued prospectively til June 2022. The study had selected eligible patient recorded for inclusion by free practice physicians and hospital physicians. General data, medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer, etc.), clinical course and complications were therefore recorded in a structured and anonymized database. Data collection was carried out by DACIMA Clinical Suite® solution, in accordance with the normative and regulatory provisions in force in the management of health data.
- Conditions
- COVID-19 Disease
- Being tested
- routinely collected clinical information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routinely collected clinical informationOther
medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer,etc...)
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of patients with COVID-19 who have developed de novo diabetes.
The de novo diabetic patient is defined as follows: Fasting blood glucose ≥ 1.26 g/L (7mmol/L) or postprandial blood glucose ≥ 2g/L (11.1 mmol/L) within 2 weeks of COVID- 19 infection, no history of diabetes before the COVID-19 episode.
Measured: 3 months
Secondary outcomes (1)
Demographic characteristics of diabetic patients
age, weight, gender, BMI, age of diabetes, diabetes treatments, type of diabetes, diabetes complications, comorbidities (hypertension, heart disease, dyslipidemia), vaccination status (number of doses, type of vaccine), associated treatments, hospitalization, evolution (use of respiratory support, cure, death following COVID-19 infection in diabetic and non-diabetic patients).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start23 Mar 2022
- Primary completion30 Jun 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 811 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Faida AJILI, Pr., Principal investigator, Department of Internal Medicine at the Military Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603130
- Sponsor's protocol ID
- CoviDTUN
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 2 Nov 2022
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes and COVID-19 in Tunisia (CoviDTUN)
- ClinicalTrials.gov ID
- NCT05603130
- Acronym / sponsor ID
- CoviDTUN
- Conditions
- COVID-19 Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 2 Nov 2022 (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.
CoviDTUN is a multicenter observatory set up by a steering committee to determine the presentation and evolution of diabetes in COVID-19 and study its pathogenesis.
The observatory comprises a dataset consisting of routinely collected clinical information anonymously to be entered by the investigator as a participating clinician/researcher.
The study will be an opportunity to understand the relationship between COVID-19 and diabetes, to enrich Tunisian data on diabetic and de novo diabetic patients who have contracted COVID-19 and to evaluate the prognostic severity factors for better management of these patients.
Detailed description
It is a multicentric Tunisian observatory for COVID-19 patients. Confirmed COVID-19 patients, treated on an outpatient basis, in containment centers or hospitalized in COVID-19 units were included retrospectively from March 2020 and had continued prospectively til June 2022. The study had selected eligible patient recorded for inclusion by free practice physicians and hospital physicians. General data, medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer, etc.), clinical course and complications were therefore recorded in a structured and anonymized database. Data collection was carried out by DACIMA Clinical Suite® solution, in accordance with the normative and regulatory provisions in force in the management of health data.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed COVID-19 patients, treated on an outpatient basis, in containment centers or hospitalized in COVID-19 units.
Key inclusion criteria (4 listed)
- Diagnosis of COVID-19 infection confirmed by an evocative clinical picture according to INEAS score or a positive polymerase chain reaction [PCR] test and/or chest CT specific radiological signs and/or a rapid diagnostic antigen test.
- Diabetes known before COVID-19 (known diabetes patient before COVID-19: Diabetic patient before COVID-19: History in medical record and/or presence of antidiabetic therapy and/or HbA1c ≥ 6.5%).
- or
- De novo diabetes (the de novo diabetic patient is defined as: Fasting blood glucose ≥ 1.26 g/L (7mmol/L) or postprandial blood glucose ≥ 2g/L (11.1 mmol/L) within 2 weeks of COVID-19 infection, no history of diabetes before the COVID-19 episode)).
Key exclusion criteria (2 listed)
- children
- pregnant women
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 |
|---|---|---|
| routinely collected clinical informationmedical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer,etc...) | Other | – |
Primary outcome
Effectiveness of patients with COVID-19 who have developed de novo diabetes.
Time frame: 3 months
The de novo diabetic patient is defined as follows: Fasting blood glucose ≥ 1.26 g/L (7mmol/L) or postprandial blood glucose ≥ 2g/L (11.1 mmol/L) within 2 weeks of COVID- 19 infection, no history of diabetes before the COVID-19 episode.
1 secondary outcome
Demographic characteristics of diabetic patients
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- 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.
Faida AJILI, Pr. principal investigator
Department of Internal Medicine at the Military Hospital of Tunis
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 Disease, run by Les Laboratoires des Médicaments Stériles 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 4 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: finished, as of the sponsor's last update on 2 Nov 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of patients with COVID-19 who have developed de novo diabetes. (time frame: 3 months). 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 2 Nov 2022.