Validation of Prognostic Clinical Risk Scores in Predicting Outcome for Patients With COVID-19 at Initial Triage

Summary

Background Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) causing Covid-19 pandemic continues to be a global health threat with a massive burden on health care systems resulting in more than six million deaths in 188 countries. Because of wide clinical spectrum of disease severity, having clinically applicable prognostic tools for early identification of patients at high risk of progression to severe / critical illness is essential to guide clinical decision making and resource allocation efforts. So far, clinical prognostic tools have focused on host factors, but more recent data indicated a significant association between SARS-CoV-2 variants and the development of complications such as long COVID.

Objectives

1. Validation of the ALA \& ALKA prediction tools for initial evaluation of patients diagnosed with COVID-19 infection.
2. Comparison of performance of the ALA \& ALKA prediction tools with the currently clinical risk assessment scoring system used during initial evaluation of patients diagnosed with COVID-19 infection.
3. Evaluation of the clinical risk assessment scoring based on number of comorbidities in prediction of COVID-19 related complications
4. Assessment of the association between SARS-CoV-2 variants and the risk of COVID-19 severity
5. Assessment of the impact of SARS-CoV-2 variants on the performance of ALA \& ALKA prediction tools

Methods Data will be abstracted from electronic medical records including demographics, clinical manifestation, comorbidities, and initial laboratory data in patients with Covid 19 infection of around 2000 patients presented initially to COVID assessment centre, including SARS CoV-2 sequencing data. Furthermore, population level SARS-CoV-2 RNA sequence data will also be examined and correlated with COVID-19 severity and the performance of prediction tools.

Conditions

• COVID-19

Interventions

OTHER

logistic regression of known prognostic markers of severity of COVID19

An observational longitudinal follow up of all consecutive patients with positive SARS-CoV-2 testing on nasopharyngeal swabs per WHO definitions presenting to the emergency department . The risk assessment score at initial presentation will be calculated for each patient using clinical assessment scoring of ALA \& ALKA and compared with the currently proposed clinical risk assessment scoring system The utility of the risk score in triaging patients on their initial visits to emergency department (ED) will be validated against the following measured outcomes: 1. Hospital admission on the first encounter to ED 2. Admission to ICU for the duration of the COVID-19 hospitalization 3. In hospital and out of hospital mortality 4. Return to ED following initial discharge (within the current covid illness period, Maximum 30 days from the initial diagnosis)

Sponsors & Collaborators

• Abu Dhabi Health Services Company

  collaborator OTHER_GOV

• Dr Adnan Agha

  lead OTHER

Principal Investigators

• Adnan Agha · United Arab Emirates University

Eligibility

Min Age

16 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2023-12-31

Completion

2024-01-31

Countries

• United Arab Emirates

Study Locations