Clinical trial NCT06354946: External Validation of Simplified 4C Mortality Score by Deleting CRP
Official title: External Validation of Simplified 4C Mortality Score by Deleting CRP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Keywords: SCORE 4C
SARS-COV2
validation
deleting CRP
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome was all-cause in-hospital mortality rate The primary outcome was all-cause in-hospital mortality rate
timeFrame: 30 days after inclusion
Secondary outcomes:
measure: Number of patients admitted to the ICU
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: EPS Fattouma Bourguiba University hospital
Study officials:
affiliation: CHU Fattouma Bourguiba Monastir, service des urgences
name: Khaoula Bel Haj Ali
role: PRINCIPAL_INVESTIGATOR
References: