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

COVID-19 Pandemic Clinical Trial

— 4C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498324
• Other study ID #: 4C Score
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2023
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University Hospital	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

References & Publications (2)

Gordon AJ, Govindarajan P, Bennett CL, Matheson L, Kohn MA, Camargo C, Kline J. External validation of the 4C Mortality Score for hospitalised patients with COVID-19 in the RECOVER network. BMJ Open. 2022 Apr 21;12(4):e054700. doi: 10.1136/bmjopen-2021-054700. — View Citation

Knight SR, Gupta RK, Ho A, Pius R, Buchan I, Carson G, Drake TM, Dunning J, Fairfield CJ, Gamble C, Green CA, Halpin S, Hardwick HE, Holden KA, Horby PW, Jackson C, Mclean KA, Merson L, Nguyen-Van-Tam JS, Norman L, Olliaro PL, Pritchard MG, Russell CD, Shaw CA, Sheikh A, Solomon T, Sudlow C, Swann OV, Turtle LCW, Openshaw PJM, Baillie JK, Docherty A, Semple MG, Noursadeghi M, Harrison EM; ISARIC Coronavirus Clinical Characterisation Consortium (ISARIC4C) Investigators; ISARIC4C investigators. Prospective validation of the 4C prognostic models for adults hospitalised with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol. Thorax. 2022 Jun;77(6):606-615. doi: 10.1136/thoraxjnl-2021-217629. Epub 2021 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was all-cause in-hospital mortality rate	The primary outcome was all-cause in-hospital mortality rate	30 days after inclusion
Secondary	ICU admission rate	ICU admission rate	30 days after inclusion
Secondary	combined outcome	all-cause in-hospital mortality and/or ICU admission	30 days after inclusion