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

NCT ID: NCT04584606

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-27

Study Completion Date

2020-12-30

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.

Conditions

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Coronavirus Disease (COVID-19)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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culture, imaging

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ashraf A Elmaraghy

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashraf Elmaraghy

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University, Faculty of Medicine

Locations

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Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ashraf Elmaraghy

Role: CONTACT

+20 100 177 0703

Facility Contacts

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Fatma Soliman E Ebeid

Role: primary

01095569596

Other Identifiers

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FMASU P30/ 2020

Identifier Type: -

Identifier Source: org_study_id

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