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COVID-19 Infection in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT04765254
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Dalia K. Zaafar, Cairo University

Study Description
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Brief Summary:
It was observed during the last period of COVID-19 pandemic that diabetic patients had a worse prognosis and more deteriorated clinical features than other patients

Condition or disease Intervention/treatment
Covid19 Diabete Type 2 Non Diabetic Patients Chest CT Scan Other: no intervention as it is an observational study

Detailed Description:
Diabetic patients infected with SAR-COV-19 were reported to have worse prognosis and faster deterioration in addition to higher rate for ICU admission when compared to other infected patients. In this study authors aim to investigate the certain cause for their case deterioration to be modified for better prognosis
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Features of Diabetic Patients With COVID-19 Infection
Actual Study Start Date : February 20, 2021
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
control group
COVID-19 infected patients with no other comorbidities and they take the routine protocol from the Egyptian ministry of health
 Other: no intervention as it is an observational study
both groups will be monitored for the disease progress or deterioration and mortality rate
diabetic group
COVID-19 infected patients with diabetes comorbidity and they receive the routine protocol for covid treatment in addition to their hypoglycemic drugs
 Other: no intervention as it is an observational study
both groups will be monitored for the disease progress or deterioration and mortality rate


Outcome Measures
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Primary Outcome Measures :
  1. Investigation of bad prognosis cause for covid-19 diabetic patients [ Time Frame: 30 days ]
    number of diabetic patients with deteriorated case and to find the best hypoglycemic drug used for diabetic patients with covid-19 infection


Biospecimen Retention:   Samples Without DNA
serum samoles for routine CBC, D dimer and INR tests

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients infected with COVID-19 either diabetic or have no comorbidities, inpatients
Criteria

Inclusion Criteria:

Patients infected with COVID-19 male or female 30 years old or more inpatients

Exclusion Criteria:

  • have othe comorbidities other than type 2 diabetes mellitus pregnant women below 30 years old
Contacts and Locations
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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): NCT04765254


Contacts
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Contact: Dalia Zaafar, PhD +201117922833 dr.moda88@gmail.com
Contact: Amal Ahmed, PhD +201224847367 amalahmedhcp@yahoo.com

Locations
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Egypt
Cairo University teaching hospitals Recruiting
Cairo, Kasr Al Ainy, Egypt, 11311
Contact: Amal Ahmed, PhD    +201224847367    amalahmedhcp@yahoo.com   
Contact: Dalia Zaafar, PhD    +201117922833    dr.moda88@gmail.com   
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Dalia K. Zaafar, lecturer of pharmacology, Cairo University
ClinicalTrials.gov Identifier: NCT04765254    
Other Study ID Numbers: ITH00131
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dalia K. Zaafar, Cairo University:
COVID-19
prognosis
mortality rate
Diabetes Mellitus
Additional relevant MeSH terms:
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COVID-19
Diabetes Mellitus, Type 2
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases