NCT06354946

External Validation of Simplified 4C Mortality Score by Deleting CRP

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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.

Conditions

• COVID-19 Pandemic

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-11-30
• Completion: 2022-12-30
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: Tunisia