Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634214
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2020-11-15
Brief Title:
The Severity of COVID 19 in Diabetes and Non-diabetes Patients
Sponsor:
India Diabetes Research Foundation Dr A Ramachandrans Diabetes Hospitals
Organization:
India Diabetes Research Foundation Dr A Ramachandrans Diabetes Hospitals
Study Overview
Official Title:
Study on Characteristics and Prognosis of Diabetes and Non Diabetes Patients With COVID 19 Among Southern Indian Population
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVID19
Brief Summary:
There were 8385440 confirmed cases of COVID-19 worldwide with a mortality rate of 54 according to the situation report of the World Health Organisation on June 19 2020 In India there were 395048 confirmed cases of COVID-19 with a mortality rate of 33 In Tamil Nadu there were 54449 confirmed cases of COVID-19 with a mortality rate of 12 according to the report of Ministry of Health and Family Welfare Government of India on June 19 2020
COVID-19 infection is a double challenge for people with diabetes India has a large number of persons with diabetes more than 77 million Recent studies have reported rising prevalence both in the urban and rural populations The incidence of type 2 diabetes T2D also shows an increasing trend in the last few decades Mortality seems to be threefold higher in people with diabetes when COVD-19 coexists when compared with mortality due to COVID-19 without comorbidities
Yang et al noted that among 52 intensive care patients who had COVID 19 infection 22 had diabetes among the non-survivors In a study of 173 patients with severe disease 162 had diabetes and in another study of 140 hospitalized patients 12 had diabetes Li et al compared intensive care and non-intensive care patients who had COVID-19 They showed a twofold increase in the incidence of diabetes in intensive care patients
In addition to diabetes the other common co-morbidities present in COVID 19 patients were hypertension 20 cardiovascular disease 16 and lung disease 6 In this context patients with diabetes have been listed as people with higher severity for COVID-19 by several health authorities However precise data regarding patients with and without diabetes having COVID-19 infection are still lacking Moreover the relationship between diabetes and the severity of COVID-19 remains unknown In this study we intend to identify the disease severity and mortality in people with and without diabetes admitted for COVID-19 in southern India
COVID-19 infection is a double challenge for people with diabetes India has a large number of persons with diabetes more than 77 million Recent studies have reported rising prevalence both in the urban and rural populations The incidence of type 2 diabetes T2D also shows an increasing trend in the last few decades Mortality seems to be threefold higher in people with diabetes when COVD-19 coexists when compared with mortality due to COVID-19 without comorbidities
Yang et al noted that among 52 intensive care patients who had COVID 19 infection 22 had diabetes among the non-survivors In a study of 173 patients with severe disease 162 had diabetes and in another study of 140 hospitalized patients 12 had diabetes Li et al compared intensive care and non-intensive care patients who had COVID-19 They showed a twofold increase in the incidence of diabetes in intensive care patients
In addition to diabetes the other common co-morbidities present in COVID 19 patients were hypertension 20 cardiovascular disease 16 and lung disease 6 In this context patients with diabetes have been listed as people with higher severity for COVID-19 by several health authorities However precise data regarding patients with and without diabetes having COVID-19 infection are still lacking Moreover the relationship between diabetes and the severity of COVID-19 remains unknown In this study we intend to identify the disease severity and mortality in people with and without diabetes admitted for COVID-19 in southern India
Detailed Description:
The following data from a person tested positive for COVID 19 and hospitalized will be collected Patients anthropometry height in cms weight in kgs and body mass index in kgm2 blood pressure symptoms of COVID-19 fever fatigue cough cephalalgia dyspnoea rhinitis pharyngeal symptoms ageusia anosmia digestive disorders history of smoking hypertension dyslipidemia microvascular retinopathy nephropathy and neuropathy macrovascular coronary artery disease cerebrovascular disease and peripheral vascular disease complications and other co morbid conditions will be recorded Fasting blood glucose HbA1c and any other relevant investigations if available and treatment for COVID-19 and other co morbid conditions will be recorded
Details of patients developing new symptoms shifted to ICU intubated or died during the course of treatment will be recorded Appearance of any complication during the stay at hospital will be recorded The changes in the treatment pattern during the course of the disease will also be noted
The registry will be fully anonymised and statistician will have no access to patients personal identifiers All investigators will have to register before entering data in the registry Data about clinical observations for the individual patient will be entered by clinicians or by authorised research personnel of the care team in the web registry
Patients name date of birth date of death residential postal code hospital number will be fully anonymised at source In no circumstances patients identifiable data be available to anyone outside their own care teams or authorised local administrationresearch personnel Patient data will not at any stage will be in identifiable form by the registry managers The data to be collected from the patients are mentioned in the visit chart
Details of patients developing new symptoms shifted to ICU intubated or died during the course of treatment will be recorded Appearance of any complication during the stay at hospital will be recorded The changes in the treatment pattern during the course of the disease will also be noted
The registry will be fully anonymised and statistician will have no access to patients personal identifiers All investigators will have to register before entering data in the registry Data about clinical observations for the individual patient will be entered by clinicians or by authorised research personnel of the care team in the web registry
Patients name date of birth date of death residential postal code hospital number will be fully anonymised at source In no circumstances patients identifiable data be available to anyone outside their own care teams or authorised local administrationresearch personnel Patient data will not at any stage will be in identifiable form by the registry managers The data to be collected from the patients are mentioned in the visit chart
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None