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

• Conditions: Coronavirus Disease (COVID-19)

• Registration Number: NCT04584606
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2020-06-27
• Status Verified: 2020-10
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-10
• Last Update Submitted: 2020-10-10
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Read More

Exclusion Criteria

• mild cases who don't need hospitalization

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recovery	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
Mortality	Until patient is discharged or up to 12 weeks whichever comes first	All cause mortality

Secondary Outcome Measures

Name	Time	Method
Conversion of nucleic acid testing for SARS-CoV-2 from positive to negative.	Until patient is discharged or up to 12 weeks whichever comes first	Detected by Polymerase Chain Reaction (PCR) test for nasopharyngeal swab
Radiological progression of the COVID 19 disease	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
Functional progression of the COVID 19 disease	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

Trial Locations

Locations (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center; 🇪🇬 Cairo, Non-US, Egypt