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Clinical Trials/NCT05582382
NCT05582382RecruitingNot Applicable

Validation of Prognostic Clinical Risk Scores in Predicting Outcomes for Patients Diagnosed With COVID-19 During Initial Triage Assessment

Dr Adnan Agha1 site in 1 country2,000 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,000
Locations
1
Primary Endpoint
Validation of the ALA & ALKA prediction tools

Study Overview

Brief 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.

Detailed Description

Background:

Since December 2019, when severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) causing COVID -19 disease emerged in Wuhan city and on 11 March 2020 rapidly spread into the rest of the world including UAE as a pandemic. COVID-19 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 (1).

COVID-19 infection is characterized by a wide clinical spectrum of disease severity ranging from asymptomatic illness to severe disease that may progress to life-threatening complications such as shock and acute respiratory distress syndrome (2). Thus, having clinically applicable prognostic tools for early identification of symptomatic patients at high risk of progression to severe / critical illness is essential to guide allocating limited healthcare resources (3). 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 (4).

Currently, the clinical assessment for patients with COVID-19 infection is based on patient's age, number of comorbidities, subjective symptoms, and extent of pulmonary infiltrate on radiological examination which makes early prediction of severe / critical illness rather difficult (5-7). A recently published prognostic prediction tools (ALA & ALKA) were proposed to aid triaging patients with COVID-19 infection on initial diagnosis (8). These prediction tools are based on simple readily available laboratory tests and therefore may offer a clear advantage over other tools to guide discharge and admission decisions in triage assessment centers Nevertheless, external validation of these simple tools using another cohort of patients would provide a stronger evidence to support their utility in triaging patients on initial diagnosis. In addition, it will also allow further optimization of these tools to improve their utility as clinical decision support tools to triage patients on initial diagnosis. Patients deemed to be high risk based on these predictive tools could be triaged to hospital admission where intensive care unit (ICU) is available in anticipation of worse outcome. Therefore, these patients may benefit from earlier initiation of the required level of care and support including specific therapy.

The aim of this study is to validate and compare the ALA & ALKA prediction tools with the currently clinical risk assessment scoring system proposed for initial evaluation of patients with COVID-19 infection.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
16 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All consecutive patients with positive SARS-CoV-2 testing on nasopharyngeal swabs per WHO definitions presenting to the emergency department
  • All patients admitted to the hospital for isolation purposes only

Exclusion Criteria

  • Inconclusive PCR results on initial or repeat results with 24 hours

Outcomes

Primary Outcomes

Validation of the ALA & ALKA prediction tools

Time Frame: 12 months

Validation of the ALA \& ALKA prediction tools for initial evaluation of patients diagnosed with COVID-19 infection

Secondary Outcomes

  • Comparison of performance of the ALA & ALKA prediction tools with current clinical risk tools(12 months)

Investigators

Sponsor
Dr Adnan Agha
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Adnan Agha

Assistant Professor, Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University

United Arab Emirates University

Study Sites (1)

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