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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronavirus Disease (COVID-19)

Intervention / Treatment
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* Diagnostic Test: Lab workup (on admission and regularly during follow up).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Lab workup (on admission and regularly during follow up).|Complete blood count with differential leucocytic count. Absolute lymphocytic and neutrophilic count. Liver functions: Aspartate transaminase and Alanine transaminase . Renal functions: Blood urea nitrogen, serum Creatinine. HbA1C. C-reactive protein (quantitative). Serum ferritin level. D - dimer level (quantitative). Coagulation profile (Prothrombin time/ Partial thromboplastin time/ International normalized ratio). Troponin level. Arterial blood gases when needed.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery | 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 | 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. | 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 | 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 | 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 |