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Clinical Trials/NCT05218265
NCT05218265
Completed
Not Applicable

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

Zagazig University1 site in 1 country202 target enrollmentMarch 1, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Zagazig University
Enrollment
202
Locations
1
Primary Endpoint
assessing severity of COVID-19
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
July 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmad Abbas

Assistant professor of chest diseases

Zagazig University

Eligibility Criteria

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

Outcomes

Primary Outcomes

assessing severity of COVID-19

Time Frame: 30 days from admission

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 \[according to 16.National Health Commission of China. The novel coronavirus pneumonia diagnosis and treatment program, 7th version. China. 2020.http://www.nhc.gov.cn/yzygj/s7653p/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml. Accesed 04 Apr.\]

Study Sites (1)

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