Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05218265
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2022-01-30
Brief Title:
Criteria and Potential Predictors of Severity in Patients With COVID-19
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Criteria and Potential Predictors of Severity in Patients With COVID-19
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mildmoderate cases group B included severecritical 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 andor ratio of arterial oxygen partial pressure to fractional inspired oxygen 300 mmHg PaO2FIO2 and critical aforementioned criteria of respiratory failure receiving mechanical ventilation shock andor organ failure other than lung andor 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
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 mildmoderate cases group B included severecritical 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 andor ratio of arterial oxygen partial pressure to fractional inspired oxygen 300 mmHg PaO2FIO2 and critical aforementioned criteria of respiratory failure receiving mechanical ventilation shock andor organ failure other than lung andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None