Criteria and Potential Predictors of Severity in Patients With COVID-19

This is an observational cross sectional study included 202 patients diagnosed to have COVID-19. The study was conducted at Zagazig University Isolation Hospitals from the period of March 2020 to June 2021. The study was approved by Zagazig University Ethics Committee (number 9229). A written informed consent was obtained from all participants.

Inclusion criteria:

The study includes laboratory confirmed COVID-19 patients (confirmed by real-time polymerase chain reaction) admitted l during the period of the study.

The patients were classified into two groups, group A included mild/moderate cases, group B included severe/critical cases according to the following criteria.

Severity of COVID-19 was graded as follows: mild; mild clinical symptoms, no pneumonia on lung CT; moderate: fever, cough and lung CT with pneumonia; severe: respiratory distress (respiratory rate > 30 /min, oxygen saturation (O2Sat) ≤ 93 percent at rest and/or ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤300 mmHg (PaO2/FIO2); and critical: aforementioned criteria of respiratory failure receiving mechanical ventilation, shock, and/or organ failure other than lung and/or intensive care unit (ICU) hospitalization.

All participants were subjected to full history taking including smoking history and comorbidity profile. Clinical symptoms including: fever, cough, dyspnea, myalgia, hemoptysis, sore throat, diarrhea, loss of smell and anorexia were recorded. Radiological assessment by initial chest x ray then CT chest as possible and appropriate. Routine laboratory investigations: Complete blood count (CBC), coagulation profile, serum biochemical tests (including renal and liver function, and electrolytes), laboratory investigation to assess severity of COVID-19: lactate dehydrogenase (LDH), myocardial enzymes (CPK-MB), serum ferritin, D dimer and arterial blood gases analysis. Patients were followed up for the need for ICU and mechanical ventilation (MV), duration till conversion, total length of stay and final outcome whether survived or died were recorded.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: routine laboratory tests

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• Egypt
  • Asharqia
    • Zagazig, Asharqia, Egypt, 44519
      • Zagazig University Faculty of medicine Chest Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is an observational cross sectional study included 202 patients diagnosed to have COVID-19. The study was conducted at Zagazig University Isolation Hospitals from the period of March 2020 to June 2021.

Description

Inclusion Criteria:

• laboratory confirmed COVID-19 patients (confirmed by real-time polymerase chain reaction) admitted during the period of the study.

Exclusion Criteria:

• age less than 18
• refusal to participate
• referral to other hospital within 24 hours of admission
• missing data registry

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessing severity of COVID-19	Severity of COVID-19 was graded as follows: (1) mild; mild clinical symptoms, no pneumonia on lung CT; (2) moderate: fever, cough and lung CT with pneumonia; (3) severe: respiratory distress (respiratory rate > 30 /min, oxygen saturation (O2Sat) ≤ 93 percent at rest and/or ratio of arterial oxygen partial pressure to fractional inspired oxygen ≤300 mmHg (PaO2/FIO2); and (4) critical: aforementioned criteria of respiratory failure receiving mechanical ventilation, shock, and/or organ failure other than lung and/or intensive care unit (ICU) hospitalization [according to 16.National Health Commission of China. The novel coronavirus pneumonia diagnosis and treatment program, 7th version. China. 2020.http://www.nhc.gov.cn/yzygj/s7653p/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml. Accesed 04 Apr.]	30 days from admission

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: January 30, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 9229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No