Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06354946 |
Other study ID # |
SCORE 4C |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
December 30, 2022 |
Study information
Verified date |
April 2024 |
Source |
University of Monastir |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.