NCT05677789

Defining COVID-19 Infection Severity on Presentation to Hospital

Defining COVID-19 Infection Severity on Presentation to Hospital: a Multicentre Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In the assessment of severity in coronavirus disease 2019 (COVID-19), the modified Brit\_x0002\_ish Thoracic Society (mBTS)，CURB65 et al. rules identifies patients with severe pneumonia but not patients who might be suitable for home management. A multicentre prospective study was conducted to derive and validate a practical severity assessment model for stratifying adults hospitalised with COVID-19 into different management groups.

Detailed description

1. Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures. 2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria. 3. The following is the general sequence of events during the 30-day evaluation period: 4. Completion of baseline procedures Participants were assessed for 30 days and completed all safety monitoring.

Conditions

• COVID-19
• Infections
• Morality
• Death, Assisted

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Medical observation	Likely suitable for home treatment
DIAGNOSTIC_TEST	Supportive treatment (BSC)	Consider hospital supervised treatment
DIAGNOSTIC_TEST	Intensive care management	Manage in hospital as severe pneumonia

Timeline

• Start date: 2023-01-04
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-01-10
• Last updated: 2023-01-10

Locations

1 site across 1 country: China