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

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clinicaltrials.gov/study/NCT05218265
Is a
‌
Clinical study
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Clinical Study attributes

NCT Number
NCT052182650
Health Conditions in Trial
COVID-19
COVID-19
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Trial Recruitment Size
2020
Trial Sponsor
Zagazig University
Zagazig University
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Clinical Trial Start Date
March 1, 2020
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Primary Completion Date
June 30, 2021
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Study Completion Date
July 30, 2021
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Case-Only0
Observational Study Perspective
Prospective0
Official Name
Criteria and Potential Predictors of Severity in Patients With COVID-190
Last Updated
February 25, 2022
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Study 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.

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