Defining COVID-19 Infection Severity on Presentation to Hospital

Recruiting

• Conditions: Infections; Morality; COVID-19; Death, Assisted

• Registration Number: NCT05677789
• Lead Sponsor: Fuzhou General Hospital

Brief 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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-04
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-07
• Last Update Submitted: 2023-01-07
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition);
2. Participants are willing to participate in this study and follow the research plan;
3. Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website.

Exclusion Criteria

1. pneumonia was (a) not the primary cause for hospital admission, (b) an expected terminal event,or (c) distal to bronchial obstruction;
2. patients with tuberculosis,bronchiectasis,solid organ and haematological malignancies or human immuno deficiency virus (HIV) infection;
3. patients who had been in hospital within the previous 14days, were immunocompromised,or had previously been entered in the study;
4. nursing home residents.Participation in other clinical study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deterioration of the condition	Day 1 to 30 days	Deterioration of the condition: refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 9) The development from asymptomatic to mild/general-type. The development from mild to general-type/severe type The development from general-type to severe/critical type The development from severe to critical type
Mortality	30days	Mortality within 30days after diagnosis; Death from any cause

Secondary Outcome Measures

Name	Time	Method
Safety assessment Results: such as AEs and SAEs through Day 30	Up to 30 days	Safety assessment Results: such as AEs and SAEs through Day 30
Percentage of participants with no clinical symptom	Day 3, 5, 7, 10, 14, 21 and 28	Percentage of participants with no clinical symptoms from baseline to Day 3, 5, 7, 10, 14, 21 and 28
Percentage of participants who turned negative for SARS-CoV-2 and/or COVID-19 antigen	Day 3, 5, 7, 10, 14, 28	Percentage of participants who turned negative for SARS-COV-2 COVID-19 antigen at Day 3, 5, 7, 10, 14, 28
Time to sustained disappearance of clinical symptoms	Up to 30 days	Time to sustained disappearance of clinical symptoms

Trial Locations

Locations (1)

The 900th Hospital of the Joint Logistic Support Force, PLA; 🇨🇳 Fuzhou, Fujian, China