NCT04634214

Brief Summary

There were 83,85,440 confirmed cases of COVID-19 worldwide with a mortality rate of 5.4% according to the situation report of the World Health Organisation on June 19, 2020. In India there were 3,95,048 confirmed cases of COVID-19 with a mortality rate of 3.3%. In Tamil Nadu there were 54,449 confirmed cases of COVID-19 with a mortality rate of 1.2% 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, 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2021

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 15, 2020

Last Update Submit

November 17, 2020

Conditions

Covid19Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Severity of COVID 19 among people with and without diabetes

    To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infection

    Up to 1 month

Secondary Outcomes (6)

  • Number of patients who were in ICU

    Up to 1 month

  • Number of patients who had tracheal intubation

    Up to 1 month

  • Number of patients who had respiratory complication

    Up to 1 month

  • Number of death

    Up to 1 month

  • Correlation of BMI with complications, tracheal intubation and mortality

    Up to 1 month

  • +1 more secondary outcomes

Study Arms (2)

COVID 19 positive patients without diabetes

COVID 19 positive patients without diabetes

COVID 19 positive patients with diabetes

COVID 19 positive patients with diabetes

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID 19 positive patients with or without diabetes

You may qualify if:

  • \>18 yrs male or female
  • COVID-19 positive

You may not qualify if:

  • COVID 19 Negative
  • New-onset Diabetes with covid-19 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orthomed Hospital

Chennai, Tamil Nadu, 600014, India

Location

Medway Hospital

Chennai, Tamil Nadu, 600024, India

Location

Venkateswara Hospital

Chennai, Tamil Nadu, 600035, India

Location

Dr. Rela Institute & Medical Center

Chennai, Tamil Nadu, 600044, India

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ambady Ramachandran, M.D,PhD,DSc

    President

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ambady Ramachandran, M.D,PhD,DSc

CONTACT

044-22353730research@ardiabetes.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 18, 2020

Study Start

November 16, 2020

Primary Completion

February 16, 2021

Study Completion

May 16, 2021

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(4)