Comorbidities And Complications Associated With Covid-19 Infection

June 13, 2022 updated by: Mahmoud Gamal Hussein, Assiut University
To evaluate the spectrum of comorbidities and complications and its impact on the clinical outcome in hospitalized patients with coronavirus disease 2019 (COVID-19).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) is a coronavirus with human infection designated as COVID-19 by the World Health Organization. Bats and birds serve as the typical coronavirus hosts, with zoonotic spread and a long-documented history of animal-animal-human transmission.

Since November 2019, the rapid outbreak of coronavirus disease 2019 (COVID-19), which arose from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, has recently become a public health emergency of international concern. COVID-19 has contributed to an enormous adverse impact globally.

As of 10 March 2020 there have been 113702 laboratory confirmed cases and 4012 deaths globally.

According to the latest reports, the clinical manifestations of COVID-19 are heterogeneous. On admission, 20-51% of patients were reported as having at least one comorbidity, with diabetes (10-20%), hypertension (10-15%) and other cardiovascular and cerebrovascular diseases (7-40%) being most common. Previous studies have demonstrated that the presence of any comorbidity has been associated with a 3.4-fold increased risk of developing acute respiratory distress syndrome in patients with H7N9 infection. As with influenza, SARS-CoV and Middle East Respiratory Syndrome coronavirus (MERS-CoV), COVID-19 is more readily predisposed to respiratory failure and death in susceptible patients.

Although it is well documented that COVID-19 is primarily manifested as a respiratory tract infection, emerging data indicate that it should be regarded as a systemic disease involving multiple systems, including cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune system. Mortality rates of COVID-19 are lower than SARS and Middle East Respiratory Syndrome (MERS); however, COVID-19 is more lethal than seasonal flu.

Older people and those with comorbidities are at increased risk of death from COVID-19, but younger people without major underlying diseases may also present with potentially lethal complications such as fulminant myocarditis and disseminated intravascular coagulopathy (DIC).

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 patients confirmed to have covid 19 infection

Description

Inclusion Criteria:

Patients presented by respiratory symptom and admitted to Assuit university hospitals in wards and intensive care units due to COVID-19 according to WHO and Egyptian Ministry of Health and Population (MOH) definitions with positive PCR result.

Exclusion Criteria:

  • Negative PCR result for suspicious cases of Covid-19,
  • Patients refusing to participate in the study.

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
covid 19
complications and comorbidities
Other: complication
complication co morbidities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of different comorbidities and covid-19 infection' complications on patient's outcome
Time Frame: baseline
Identifying characters of patients with covid-19 whose are susceptible to have different complications during the course of the disease.
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Gamal Mohamed Rabee, Proffessor, Assuit University Hospital

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 (Anticipated)

August 25, 2022

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

February 25, 2023

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • covid 19

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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