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"COVID-19 and Diabetes Outcomes" (CORONADO)

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ClinicalTrials.gov Identifier: NCT04324736
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Coronavirus Diabetes Other: no interventional study

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Study Type : Observational
Estimated Enrollment : 5497 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO
Actual Study Start Date : March 10, 2020
Actual Primary Completion Date : April 10, 2020
Estimated Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with diabetes Other: no interventional study
no interventional study

Patients without diabetes Other: no interventional study
no interventional study




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
diabetic patients treated for COVID-19 in a hospital center and non diabetic patients treated for COVID-19 in a hospital center
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324736


Contacts
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Contact: Bertrand Cariou, Pr 02 53 48 27 06 bertrand.cariou@univ-nantes.fr

Locations
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France
CHU Nantes Recruiting
Nantes, France, 44000
Contact: Bertrand Cariou, PU-PH    0253482706    bertrand.cariou@univ-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04324736    
Other Study ID Numbers: RC20_0148
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases