Covid-19 and Diabetes in West of Algeria

NCT04412746 | Unknown DMC

• 1 other identifier: COVIDIAB-13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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

1. 1.Why diabetics are more at risk of developing Covid-19 infection?
2. 2.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

Keywords

COVID-19; DIABETES; RISK FACTORS; SEVERE ILLNESS; OUTCOMES

Outcome Measures

Primary Outcomes (2)

• Prevalence of diabetes among all hospitalized COVID-19

  Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen

  3 months

• Diabetes-related factors risk

  Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

  3 months

Interventions

MANAGEMENT OF COVID-19 DRUG

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.

Also known as: MANAGEMENT OF DIABETES

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diabetic patients with COVID-19 infection admitted in academic hospital of Tlemcen (Algeria).

You may qualify if:

• 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)

You may not qualify if:

• Pregnant
• Active Cancer
• Dementia
• Minors, adults under guardianship, protected persons
• Significant disability (The Modified Rankin Scale more than 2 prior admission)

Sponsors & Collaborators

• Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen: lead
• ATRSS, DGRST, Algeria: collaborator

Study Sites (1)

Department of Internal Medicine, Acedemic Hospital of Tlemcen

Tlemcen, 130000, Algeria

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections; Diabetes Mellitus; Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Internal Medicine Department

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 2, 2020
• Study Start: April 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AL (1)