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The Severity of COVID 19 in Diabetes and Non-diabetes Patients (COVID19)

17 de novembro de 2020 atualizado por: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Study on Characteristics and Prognosis of Diabetes and Non Diabetes Patients With COVID 19 Among Southern Indian Population

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.

Visão geral do estudo

Status

Desconhecido

Condições

Descrição detalhada

The following data from a person tested positive for COVID 19 and hospitalized will be collected. Patient's anthropometry (height in cms, weight in kgs and body mass index in kg/m2), 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 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.

Tipo de estudo

Observacional

Inscrição (Antecipado)

1050

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Índia
- Tamil Nadu
  - Chennai, Tamil Nadu, Índia, 600014
    - Orthomed Hospital
  - Chennai, Tamil Nadu, Índia, 600024
    - Medway Hospital
  - Chennai, Tamil Nadu, Índia, 600035
    - Venkateswara Hospital
  - Chennai, Tamil Nadu, Índia, 600044
    - Dr. Rela Institute & Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 99 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

COVID 19 positive patients with or without diabetes

Descrição

Inclusion Criteria:

>18 yrs male or female
COVID-19 positive

Exclusion Criteria:

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
COVID 19 positive patients without diabetes
COVID 19 positive patients with diabetes

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Severity of COVID 19 among people with and without diabetes Prazo: Up to 1 month	To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infection	Up to 1 month

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Number of patients who were in ICU Prazo: Up to 1 month	Number of patients who were in ICU	Up to 1 month
Number of patients who had tracheal intubation Prazo: Up to 1 month	Number of patients who had tracheal intubation	Up to 1 month
Number of patients who had respiratory complication Prazo: Up to 1 month	Number of patients who had respiratory complication	Up to 1 month
Number of death Prazo: Up to 1 month	Number of death	Up to 1 month
Correlation of BMI with complications, tracheal intubation and mortality Prazo: Up to 1 month	Correlation of BMI with complications, tracheal intubation and mortality	Up to 1 month
Length of hospital stay Prazo: Up to 1 month	Length of hospital stay	Up to 1 month

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Investigadores

Investigador principal: Ambady Ramachandran, M.D,PhD,DSc, President

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

16 de novembro de 2020

Conclusão Primária (Antecipado)

16 de fevereiro de 2021

Conclusão do estudo (Antecipado)

16 de maio de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

15 de novembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de novembro de 2020

Primeira postagem (Real)

18 de novembro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)