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NCT Number: NCT04324736

"COVID-19 and Diabetes Outcomes"

COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death.

Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.

The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies.

This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.

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Key information

Conditions

Coronavirus Coronaviridae Infections Coronavirus Infections Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted in a hospital center since 10th march 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 (HbA1c value strictly greater than 6.5%)

Exclusion criteria

  • subjects opposed to the use of their data
  • minors, adults under guardianship, protected persons
  • subject having already been included in the CORONADO study (subject readmitted after discharge following the initial stay). Only the data of the first stay will be maintained.

Treatment and study plan

No Interventional study

Other

no interventional study

Primary outcomes

  1. Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19

    Time frame: 1 month

    Prevalence of severe forms among all COVID-19 patients with diabetes

Secondary outcomes

  1. describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

    Time frame: 1 month

    Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.

  2. describe the prognosis of hospitalized subjects with diabetes and COVID-19

    Time frame: 1 month

    death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit

  3. describe the care management of hospitalized subjects with diabetes and COVID-19

    Time frame: 1 month

    care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

"Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO

Acronym: CORONADO

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2020
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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