External Validation of the 4C Mortality Score for Hospitalised Patients With COVID-19 in a Tunisian Cohort

Completed

• Conditions: COVID-19 Pandemic

• Registration Number: NCT05498324
• Lead Sponsor: University of Monastir

Brief Summary

Risk prediction scores are important tools to support clinical decision-making for patients with coronavirus disease (COVID-19). The objective of this paper was to validate the 4C mortality score, originally developed in the United Kingdom, for a tunisian population, and to examine its performance over time.

Detailed Description

Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) can progress to acute respiratory distress syndrome, multiorgan failure, and death in some cases. The clinical presentation and progression of COVID-19 in patients is highly variable, which makes it difficult for clinicians to triage patients and determine their prognostic risk. A simple, validated prognostic tool using data that is available at presentation can help clinicians better prognosticate and support clinical decision-making . Numerous tools to predict mortality in COVID-19 patients have been developed, but many are limited due to small derivation cohort sizes and/or inadequate validation.

The 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability.

The objective of this study was to validate the 4 C Mortality risk score to predict in-hospital mortality among adults hospitalised with COVID-19 in a Tunisian cohort.

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Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-13
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• patients ≥18 years old
• admitted to one of the participating hospitals with a confirmed case of COVID-19 defined by a positive reverse transcriptase-PCR (RT-PCR) assay of a nasopharyngeal swab associated with compatible clinical manifestations

Exclusion Criteria

• under the age of 18
• Incomplete electronic records were excluded from the analysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome was all-cause in-hospital mortality rate	30 days after inclusion	The primary outcome was all-cause in-hospital mortality rate

Secondary Outcome Measures

Name	Time	Method
ICU admission rate	30 days after inclusion	ICU admission rate
combined outcome	30 days after inclusion	all-cause in-hospital mortality and/or ICU admission

Trial Locations

Locations (1)

Fattouma Bourguiba University Hospital; 🇹🇳 Monastir, Tunisia