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Defining COVID-19 Infection Severity on Presentation to Hospital

Sponsor
Fuzhou General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05677789
Collaborator
(none)
3,000
Enrollment
1
Location
11.9
Anticipated Duration (Months)
252.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Medical observation
  • Diagnostic Test: Supportive treatment (BSC)
  • Diagnostic Test: Intensive care management

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Defining COVID-19 Infection Severity on Presentation to Hospital: a Multicentre Prospective Study
Actual Study Start Date :
Jan 4, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Participants The patient's CORMB score is 0 to 2

Participants The patient's CORMB score is 0 to 2

Diagnostic Test: Medical observation
Likely suitable for home treatment
Participants The patient's CORMB score is 3 to 4

Participants The patient's CORMB score is 3 to 4

Diagnostic Test: Supportive treatment (BSC)
Consider hospital supervised treatment
Participants The patient's CORMB score is 5 or above

Participants The patient's CORMB score is 5 or above

Diagnostic Test: Intensive care management
Manage in hospital as severe pneumonia

Outcome Measures

Primary Outcome Measures

  1. Mortality [30days]

    Mortality within 30days after diagnosis; Death from any cause

  2. 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

Secondary Outcome Measures

  1. Time to sustained disappearance of clinical symptoms [Up to 30 days]

    Time to sustained disappearance of clinical symptoms

  2. 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

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The 900th Hospital of the Joint Logistic Support Force, PLA Fuzhou Fujian China 350000

Sponsors and Collaborators

  • Fuzhou General Hospital

Investigators

  • Principal Investigator: zongyang yu, Ph.D, The 900th Hospital of the Joint Logistic Support Force, PLA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fuzhou General Hospital
ClinicalTrials.gov Identifier:
NCT05677789
Other Study ID Numbers:
  • CORMB-65
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
COVID-19
Suicide, Assisted

Study Results

No Results Posted as of Jan 10, 2023