External Validation of Simplified 4C Mortality Score by Deleting CRP

NCT06354946 | Completed

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

Brief Summary

The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. we aim to validate a modified 4C score.

Conditions

COVID-19 Pandemic

Keywords

SCORE 4C; SARS-COV2; validation; deleting CRP

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

  The primary outcomes measure was in-hospital death from any cause.

  30 days after inclusion

Secondary Outcomes (1)

• Number of patients admitted to the ICU

  30 days after inclusion

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multicenter retrospective observational, cohort study of patients admitted to five Tunisian university hospitals (Fattouma Bourguiba Hospital Monastir, Sahloul Hospital Sousse, Farhat Hached Hospital Sousse, Taher Sfar Hospital Mahdia, Habib Bourguiba Hospital Sfax, Traumatology and Burns Center Tunis), the study included medical records of all adult patients with confirmed COVID-19 infection who were hospitalized from January 2020 and November 2022. A confirmed case of COVID-19 was defined by a positive reverse transcriptase-PCR (RT-PCR) assay of a nasopharyngeal swab associated with compatible clinical manifestations. Incomplete electronic record were excluded from the analysis.

You may qualify if:

• \- 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:

• Incomplete electronic records were excluded from the analysis.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

EPS Fattouma Bourguiba University hospital

Monastir, 5020, Tunisia

Location

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

• Khaoula Bel Haj Ali

  CHU Fattouma Bourguiba Monastir, service des urgences

  PRINCIPAL INVESTIGATOR

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: April 3, 2024
• First Posted: April 9, 2024
• Study Start: January 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

TU (1)