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Completed

NCT Number: NCT05498324

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

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.

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Key information

Conditions

COVID-19 Pandemic COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The primary outcome was all-cause in-hospital mortality rate

    Time frame: 30 days after inclusion

    The primary outcome was all-cause in-hospital mortality rate

Secondary outcomes

  1. ICU admission rate

    Time frame: 30 days after inclusion

    ICU admission rate

  2. combined outcome

    Time frame: 30 days after inclusion

    all-cause in-hospital mortality and/or ICU admission

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Acronym: 4C

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2022
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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