Clinical Trials Directory

Trials / Completed

CompletedNCT05218265

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

Status
Completed
Phase
Study type
Observational
Enrollment
202 (actual)
Sponsor
Zagazig University · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTroutine laboratory testsComplete 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

Timeline

Start date
2020-03-01
Primary completion
2021-06-30
Completion
2021-07-30
First posted
2022-02-01
Last updated
2022-02-25

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05218265. Inclusion in this directory is not an endorsement.