Coronavirus InfectionsCOVIDIAB-13NCT04412746
Covid-19 and Diabetes in West of Algeria
An observational study of Coronavirus Infections and Diabetes Mellitus, run by Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen at 1 site in Algeria.
Trial summary
By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Coronavirus Infections, Diabetes Mellitus, Prevalence
- What is being tested?
- MANAGEMENT OF COVID-19
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteAlgeria
- Study dates
- 1 Apr 2020to 30 Jun 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults diabetic patients with COVID-19 infection admitted in academic hospital of Tlemcen (Algeria).
Who may be able to join
- Patients admitted in a hospital center since 1th April 2020
- Patients with COVID19 with biological proof (specific PCR) or with clinical and radiological diagnosis.
- Patient with diabetes known before the admission
- New onset diabetes discovered at admission (plasma glycaemia value strictly greater than 2 g/l at any time)
Who cannot join
- Pregnant
- Active Cancer
- Dementia
- Minors, adults under guardianship, protected persons
- Significant disability (The Modified Rankin Scale more than 2 prior admission)
Trial locations and contacts
1 site in 1 country.
Algeria1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Acedemic Hospital of Tlemcen
Tlemcen, 130000
ALI LOUNICI, Professor, 00213667314275, ali.lounici@univ-tlemcen.dz
Benattou ZIANE, Professor
About this study
Official title: Prevalence of Diabetes Among Hospitalized Patients With Covid-19 in West of Algeria. Identification of Diabetes-related Associated Factors Severe Forms
By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). This exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. Algeria was part of the 13 top priority countries identified by WHO based on their direct links and volume of travel to the infected provinces in China.
It is known that some predisposing conditions lead to a worse outcome with coronavirus.
Read more
In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after full adjustment, HR 2.36).
The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms.
In the future, this study will provide answers for two main questions
- Why diabetics are more at risk of developing Covid-19 infection?
- Why diabetics are at high risk of developing severe forms?
- Conditions
- Coronavirus Infections, Diabetes Mellitus, Prevalence, Risk Factors, Patient Outcome Assessment, Severe Acute Respiratory Syndrome
- Being tested
- MANAGEMENT OF COVID-19
- Keywords
- COVID-19, DIABETES, RISK FACTORS, SEVERE ILLNESS, OUTCOMES
- Medical subject headings
- Coronavirus Infections, Diabetes Mellitus, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANAGEMENT OF COVID-19Drug
Also called MANAGEMENT OF DIABETES
MANAGEMENT OF COVID-19 Oxygen therapy to maintain SpO2 target more than 94%. Low molecular weight heparin (LMWH) at preventive doses. Empirical antibiotic treatment.
Specific treatment for COVID-19 (approved by Algerian Ministry of Health) First line: Hydroxychloroquin: 200 mg oral three times a day for 10 days, with association of Azithromycin 250 mg oral : 500 mg the first day and 250 mg once a day for 4 days. Sulfate de Zinc : 220 mg once a day for 5 days. Second line: Lopinavir/ritonavir capsule 200 mg/50 mg, oral 2 capsules each times, twice a day during 5 to 7 days.
IF AGGRAVATION OR CRITICAL ILL CONDITION AT PRESENTATION Increase oxygenation flow. Consider Glucocorticoids. 3. Consider the diagnosis of pulmonary embolism and treat with LMWH at therapeutic doses.
MANAGEMENT OF DIABETES Discontinue metformin. Start or adjust insulin doses according to personalized glycemic target of patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diabetes among all hospitalized COVID-19
Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen
Measured: 3 months
Diabetes-related factors risk
Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19
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 Jun 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen
- Sponsor type
- Research network
- Collaborators
- ATRSS, DGRST, Algeria
- Responsible party
- Principal investigator, ALI LOUNICI, Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412746
- Sponsor's protocol ID
- COVIDIAB-13
- Acronym
- COVIDIAB-13
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Diabetes Among Hospitalized Patients With Covid-19 in West of Algeria. Identification of Diabetes-related Associated Factors Severe Forms
- ClinicalTrials.gov ID
- NCT04412746
- Acronym / sponsor ID
- COVIDIAB-13 / COVIDIAB-13
- Conditions
- Coronavirus Infections, Diabetes Mellitus, Prevalence, Risk Factors, Patient Outcome Assessment, Severe Acute Respiratory Syndrome
- Keywords
- COVID-19, DIABETES, RISK FACTORS, SEVERE ILLNESS, OUTCOMES
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laboratoire De Recherche Sur Le Diabete, Université de TlemcenResearch network
- Collaborators
- ATRSS, DGRST, Algeria
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 2 Jun 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.
By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). This exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. Algeria was part of the 13 top priority countries identified by WHO based on their direct links and volume of travel to the infected provinces in China.
It is known that some predisposing conditions lead to a worse outcome with coronavirus.
In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after full adjustment, HR 2.36).
The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms.
In the future, this study will provide answers for two main questions
- Why diabetics are more at risk of developing Covid-19 infection?
- Why diabetics are at high risk of developing severe forms?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults diabetic patients with COVID-19 infection admitted in academic hospital of Tlemcen (Algeria).
Key inclusion criteria (4 listed)
- Patients admitted in a hospital center since 1th April 2020
- Patients with COVID19 with biological proof (specific PCR) or with clinical and radiological diagnosis.
- Patient with diabetes known before the admission
- New onset diabetes discovered at admission (plasma glycaemia value strictly greater than 2 g/l at any time)
Key exclusion criteria (5 listed)
- Pregnant
- Active Cancer
- Dementia
- Minors, adults under guardianship, protected persons
- Significant disability (The Modified Rankin Scale more than 2 prior admission)
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 |
|---|---|---|
| MANAGEMENT OF COVID-19Also: MANAGEMENT OF DIABETESMANAGEMENT OF COVID-19 Oxygen therapy to maintain SpO2 target more than 94%. Low molecular weight heparin (LMWH) at preventive doses. Empirical antibiotic treatment. Specific treatment for COVID-19 (approved by Algerian Ministry of Health) First line: Hydroxychloroquin: 200 mg oral three times a day for 10 days, with association of Azithromycin 250 mg oral : 500 mg the first day and 250 mg once a day for 4 days. Sulfate de Zinc : 220 mg once a day for 5 days. Second line: Lopinavir/ritonavir capsule 200 mg/50 mg, oral 2 capsules each times, twice a day during 5 to 7 days. IF AGGRAVATION OR CRITICAL ILL CONDITION AT PRESENTATION Increase oxygenation flow. Consider Glucocorticoids. 3. Consider the diagnosis of pulmonary embolism and treat with LMWH at therapeutic doses. MANAGEMENT OF DIABETES Discontinue metformin. Start or adjust insulin doses according to personalized glycemic target of patient. | Drug | – |
Primary outcome
Prevalence of diabetes among all hospitalized COVID-19
Time frame: 3 months
Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen
Diabetes-related factors risk
Time frame: 3 months
Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 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.
Department of Internal Medicine, Acedemic Hospital of Tlemcen
Tlemcen, Algeria
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 Coronavirus Infections and Diabetes Mellitus, run by Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen at 1 site in Algeria.
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 5 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: status not confirmed, as of the sponsor's last update on 2 Jun 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 Algeria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of diabetes among all hospitalized COVID-19 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 Jun 2020.