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

Coronavirus Disease (COVID-19) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584606
• Other study ID #: FMASU P30/ 2020
• Status: Recruiting
• Start date: June 27, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2020
• Source: Ain Shams University
• Contact: Ashraf Elmaraghy
• Phone: +20 100 177 0703
• Email: ashrafelmaraghy[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Disease (COVID-19)
• Coronavirus Infections

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center	Cairo	Non-US

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mortality	All cause mortality	Until patient is discharged or up to 12 weeks whichever comes first
Secondary	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
Secondary	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
Secondary	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