Clinical trial NCT04412746: Covid-19 and Diabetes in West of Algeria
Official title: Prevalence of Diabetes Among Hospitalized Patients With Covid-19 in West of Algeria. Identification of Diabetes-related Associated Factors Severe Forms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infections
Diabetes Mellitus
Prevalence
Risk Factors
Patient Outcome Assessment
Severe Acute Respiratory Syndrome
Keywords: COVID-19
DIABETES
RISK FACTORS
SEVERE ILLNESS
OUTCOMES
Lead sponsor: Laboratoire De Recherche Sur Le Diabete, Université de Tlemcen
Sponsor class: NETWORK
Collaborators: name: ATRSS, DGRST, Algeria
First posted: 2020-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diabetic patients with COVID-19 infection admitted in academic hospital of Tlemcen (Algeria).

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. Why diabetics are more at risk of developing Covid-19 infection?
2. Why diabetics are at high risk of developing severe forms?


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of diabetes among all hospitalized COVID-19
timeFrame: 3 months
measure: Diabetes-related factors risk
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tlemcen
country: Algeria
facility: Department of Internal Medicine, Acedemic Hospital of Tlemcen
Study officials:
References: