Defining COVID-19 Infection Severity on Presentation to Hospital

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status: Enrolling

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

Treatments: Diagnostic Test: Intensive care management; Diagnostic Test: Supportive treatment (BSC); Diagnostic Test: Medical observation

Study type: Observational

Funder types: Other

Identifiers

NCT05677789

CORMB-65

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 3 patient groups

Participants The patient's CORMB score is 0 to 2

Description:

Participants The patient's CORMB score is 0 to 2

Treatment:

Diagnostic Test: Medical observation

Participants The patient's CORMB score is 3 to 4

Description:

Participants The patient's CORMB score is 3 to 4

Treatment:

Diagnostic Test: Supportive treatment (BSC)

Participants The patient's CORMB score is 5 or above

Description:

Participants The patient's CORMB score is 5 or above

Treatment:

Diagnostic Test: Intensive care management