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External Validation of Simplified 4C Mortality Score by Deleting CRP

External Validation of Simplified 4C Mortality Score by Deleting CRP

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06354946
Acronym
4Cs
Enrollment
1500
Registered
2024-04-09
Start date
2020-01-01
Completion date
2022-12-30
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pandemic

Keywords

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

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.

Detailed description

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. 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. The study aim to validate a modified 4C score. Methods 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. Anamnesis, clinical, paraclinical, radiological, and outcome data were collected using a validated electronic case report form (eCRF). The primary outcomes measure was in-hospital death from any cause.

Interventions

None listed

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

Inclusion criteria

\- 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

* Incomplete electronic records were excluded from the analysis.

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome was all-cause in-hospital mortality rate The primary outcome was all-cause in-hospital mortality rate30 days after inclusionThe primary outcomes measure was in-hospital death from any cause.

Secondary

MeasureTime frame
Number of patients admitted to the ICU30 days after inclusion

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026