Clinical trial NCT05218265: Criteria and Potential Predictors of Severity in Patients With COVID-19
Official title: Criteria and Potential Predictors of Severity in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-02-01
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: assessing severity of COVID-19
timeFrame: 30 days from admission
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Faculty of medicine Chest Department
state: Asharqia
Study officials:
References: