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

NCT04584606 | Unknown DMC

• 1 other identifier: FMASU P30/ 2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• Radiological progression of the COVID 19 disease

  Until patient is discharged or up to 12 weeks whichever comes first

• Functional progression of the COVID 19 disease

  Until patient is discharged or up to 12 weeks whichever comes first

Interventions

Lab workup (on admission and regularly during follow up). DIAGNOSTIC_TEST

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.

Also known as: culture, imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• mild cases who don't need hospitalization

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Non-US, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ashraf Elmaraghy

  Ain Shams University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Elmaraghy

CONTACT

+20 100 177 0703; ashrafelmaraghy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: June 27, 2020
• Primary Completion: October 31, 2020
• Study Completion: December 30, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

EG (1)