Defining COVID-19 Infection Severity on Presentation to Hospital

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

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

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

Intervention / Treatment
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* Diagnostic Test: Intensive care management
* Diagnostic Test: Medical observation
* Diagnostic Test: Supportive treatment (BSC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition); Participants are willing to participate in this study and follow the research plan; Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website. Exclusion Criteria: pneumonia was (a) not the primary cause for hospital admission, (b) an expected terminal event,or (c) distal to bronchial obstruction; patients with tuberculosis,bronchiectasis,solid organ and haematological malignancies or human immuno deﬁciency virus (HIV) infection; patients who had been in hospital within the previous 14days, were immunocompromised,or had previously been entered in the study; nursing home residents.Participation in other clinical study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants The patient's CORMB score is 0 to 2<br>Participants The patient's CORMB score is 0 to 2 | Diagnostic Test: Medical observation<br>* Likely suitable for home treatment<br>|
| Participants The patient's CORMB score is 3 to 4<br>Participants The patient's CORMB score is 3 to 4 | Diagnostic Test: Supportive treatment (BSC)<br>* Consider hospital supervised treatment<br>|
| Participants The patient's CORMB score is 5 or above<br>Participants The patient's CORMB score is 5 or above | Diagnostic Test: Intensive care management<br>* Manage in hospital as severe pneumonia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality within 30days after diagnosis; Death from any cause | 30days | 
| Deterioration of the condition | 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 | Day 1 to 30 days | 

Secondary Outcome Measures

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