Non-invasive Predictors of ICU Admission and Mortality in Initially Asymptomatic COVID-19 Patients

NCT05298852 | Completed DMC

• 1 other identifier: 00207/2020
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) can present with pulmonary and non-pulmonary manifestations or it may be asymptomatic. Asymptomatic patients have a major impact on transmission of the disease and prediction of their outcome and prognosis is challenging. We aim to identify the predictors of intensive care unit (ICU) admission and mortality in hospitalized COVID-19 patients with initially asymptomatic presentation.This was a prospective multi-center study using cohort data included all admitted patients aged 21 years and above, with different clinical presentations other (than pulmonary manifestation) and discovered to have COVID-19. Demographic data, clinical data and progression were reported. Univariate analysis and logistic regression analysis were performed to predict ICU admission and mortality during hospitalization.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Number of patients needing intensive care unit admission

  Number of patients needing intensive care unit admission

  Within 14 days of admission

• Number of patients needing non-invasive ventilation

  Number of patients needing non-invasive ventilation

  Within 14 days of admission

• Number of patients needing mechanical ventilation

  Number of patients needing mechanical ventilation

  Within 14 days of admission

Secondary Outcomes (1)

• Number of mortalities

  Within 14 days of admission

Study Arms (1)

Study population

This is a prospective multicenter study that included patients aged more than 21 years old with different clinical presentations other than pulmonary manifestation presenting to different healthcare facilities from June to December 2020. HRCT scan of the chest in order to detect COVID-19 patients was offered after signing an informed consent. Demographic data, clinical presentations, laboratory data, oxygen saturation, radiological findings in HRCT scan of the chest, SARS-CoV-2 PCR results and the need for mechanical ventilation were reported. Effects of different baseline characteristics, findings in HRCT scan of the chest on patient outcomes were analyzed.

Diagnostic Test: High resolution computed tomography of the chest

Interventions

High resolution computed tomography of the chest DIAGNOSTIC_TEST

All participants were subjected to High resolution computed tomography of the chest.

Also known as: SARS-CoV-2 PCR

Study population

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective multi-center study that included patients aged more than 21 years old with different clinical presentations other than pulmonary manifestation presenting to different healthcare facilities from June to December 2020.

You may qualify if:

• Patients aged more than 21 years old with different clinical presentations other than pulmonary manifestation presenting to different healthcare facilities from June to December 2020.

You may not qualify if:

• Patients presented with pulmonary symptoms

Sponsors & Collaborators

• Al-Azhar University: lead
• Ain Shams University: collaborator
• Helwan University: collaborator
• National Liver Institute, Egypt: collaborator
• South Valley University: collaborator

Study Sites (1)

Al-Azhar University

Cairo, 11884, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: March 28, 2022
• Study Start: June 2, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

EG (1)