Association of Comorbidities With COVID19

August 4, 2020 updated by: Hebatallah Hassan, Assiut University

Impact of Comorbidities on COVID19 Outcome

Association of Comorbidities with unfavorable COVID19 outcomes as admission to intensive care, invasive ventilation or death.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

COVID19 is a new emerging, rapidly disseminating disease that consuming most of resources of efficient healthcare systems, and several hospitals, worldwide, are currently experiencing a shortage of ICU beds for critically ill patients with COVID-19 pneumonia.

A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need hospital and/or ICU admission.

One of the most alarming clinical parameters in general is the presence comorbidities. The underlying diseases including hypertension, diabetes mellitus, respiratory system disease and cardiovascular disease, may be risk factors for severe COVID-19 patients with adverse outcomes compared with non-severe patients. Obesity is also a risk factor for COVID-19 severity with increased need to mechanical ventilation.

Chronic diseases share several features with infectious disorders, such as the proinflammatory state, and the attenuation of the innate immune response which may be linked etiologically to its pathogenesis.

Aim of the study:to assess the impact of comorbidities in patients with diagnosis of Covid-19 on outcome, in order to find the predictors of prolonged hospital stay, need for ICU admission or poor outcome

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population: Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR. All patients will be subjected to full clinical assessment, some laboratory investigations which are potential marker of disease severity.

Another studies include chest X ray and CT chest.

Description

Inclusion Criteria:

  • Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes.

Exclusion Criteria:

  • no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID19 with comorbidities

Patients with COVID19 with at least one of the following comorbidities:

  1. Hypertension
  2. Diabetes
  3. Cardiovascular disease
  4. Chronic pulmonary disease
  5. Obesity
  6. Chronic liver disease
  7. Chronic kidney disease
  8. Collagen vascular disease
  9. Autoimmune disease
  10. Malignancy
Diagnostic test: realtime PCR
Detection of SARS-CoV-2 genes by realtime PCR
COVID19 without comorbidities
Patients with COVID19 without any of the previously mentioned comorbidities
Diagnostic test: realtime PCR
Detection of SARS-CoV-2 genes by realtime PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recovery/ ICU admission/ need for mechanical ventilation
Time Frame: Baseline
The mean rate of recovery in patients with diagnosis of Covid19, who present with comorbidities at the time of hospital admission, with the mean recovery rate in patients without any of these comorbidities.
Baseline
Time to improvement
Time Frame: Baseline
Comparison of the survival curves (times to improvement) in the two groups (patients with and without comorbidities) and among patients presenting with different types of comorbidities.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Anticipated)

October 20, 2020

Study Completion (Anticipated)

November 20, 2020

Study Registration Dates

First Submitted

July 5, 2020

First Submitted That Met QC Criteria

July 5, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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