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

NCT05498324 | Completed

• 1 other identifier: 4C Score
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pandemic

Keywords

covid-19; SARS-COV2; 4c score; validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ICU admission rate

  30 days after inclusion

• combined outcome

  30 days after inclusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients included in this study had a positive SARS-CoV-2 PCR test result and were admitted through the emergency department one of the participating centers, between november 1st,2020 to December 1st, 2021.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

Location

Related 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.

  PMID: 35450898 BACKGROUND

• 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.

  PMID: 34810237 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bel Haj Ali Khaoula, MD

  CHU Fattouma Bourguiba Monastir, service des urgences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: November 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)