Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients

October 10, 2020 updated by: Ashraf A Elmaraghy, Ain Shams University

Ain Shams University Experience: Clinical Characteristics and Outcome Determinants of Hospitalized Covid-19 Patients at Ain Shams University Obour Hospital

COVID-19 as a novel disease, different disease patterns were observed worldwide, and many treatment plans were tried. So, it is important to investigate the Egyptian clinical characteristics and different factors that determine the patient's 'outcome

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Investigators will convey the Ain Shams University experience as the first university in Egypt to designate one of its hospitals (Ain Shams University Obour Hospital) for management of confirmed COVID19 cases. investigators will try to identify the characteristics of the disease as regards the clinical, laboratory and imaging abnormalities and to assess the outcome determinants. It is a retrospective observational cohort study at Ain Shams University Obour Hospital. All adult patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2)will be included.

Clinical criteria, laboratory data, radiological findings, hospital course and patient outcome will be anonymously collected from records.

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
    • Non-US
      • Cairo, Non-US, Egypt, 11566
        • Recruiting
        • Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).

Description

Inclusion Criteria:

  • Adult (≥18 years) patients from both sexes with positive nucleic acid testing for severe adult respiratory syndrome Coronavirus (SARS-CoV-2).
  • Standard of care arm of the ongoing clinical trials will be included in our study.

Exclusion Criteria:

  • mild cases who don't need hospitalization

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery
Time Frame: Until patient is discharged or up to 12 weeks whichever comes first
Recovery defined as resolution of fever without the use of antipyretics, improvement of respiratory symptoms (e.g., cough, dyspnea) and no need for supplemental oxygen
Until patient is discharged or up to 12 weeks whichever comes first
Mortality
Time Frame: Until patient is discharged or up to 12 weeks whichever comes first
All cause mortality
Until patient is discharged or up to 12 weeks whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion of nucleic acid testing for SARS-CoV-2 from positive to negative.
Time Frame: Until patient is discharged or up to 12 weeks whichever comes first
Detected by Polymerase Chain Reaction (PCR) test for nasopharyngeal swab
Until patient is discharged or up to 12 weeks whichever comes first
Radiological progression of the COVID 19 disease
Time Frame: Until patient is discharged or up to 12 weeks whichever comes first
detected by measuring the extent of pulmonary lesion in high resolution computed tomography (HRCT) of the chest
Until patient is discharged or up to 12 weeks whichever comes first
Functional progression of the COVID 19 disease
Time Frame: Until patient is discharged or up to 12 weeks whichever comes first
increase oxygen demands detected by arterial blood gases analysis and/or pulse oximeter
Until patient is discharged or up to 12 weeks whichever comes first

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ashraf Elmaraghy, Ain Shams University, Faculty of medicine

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)

June 27, 2020

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU P30/ 2020

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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