The Severity of COVID 19 in Diabetes and Non-diabetes Patients
NCT ID: NCT04634214
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1050 participants
OBSERVATIONAL
2020-11-16
2021-05-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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, 16.2% 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 administration/research 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COVID 19 positive patients without diabetes
COVID 19 positive patients without diabetes
No interventions assigned to this group
COVID 19 positive patients with diabetes
COVID 19 positive patients with diabetes
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* COVID-19 positive
Exclusion Criteria
* New-onset Diabetes with covid-19 infection
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ambady Ramachandran, M.D,PhD,DSc
Role: PRINCIPAL_INVESTIGATOR
President
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orthomed Hospital
Chennai, Tamil Nadu, India
Medway Hospital
Chennai, Tamil Nadu, India
Venkateswara Hospital
Chennai, Tamil Nadu, India
Dr. Rela Institute & Medical Center
Chennai, Tamil Nadu, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Subair Khan, M.S
Role: primary
Palaniappan T, M.D
Role: primary
Su Thillai Vallal, M.D
Role: primary
Sruti Chandrasekaran, M.D.,D.M
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IDRFARH015
Identifier Type: -
Identifier Source: org_study_id