Defining COVID-19 Infection Severity on Presentation to Hospital

NCT05677789 | Unknown

• 1 other identifier: CORMB-65
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Infections; Morality; Death, Assisted

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to sustained disappearance of clinical symptoms

  Up to 30 days

• Percentage of participants with no clinical symptom

  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

• Safety assessment Results: such as AEs and SAEs through Day 30

  Up to 30 days

Study Arms (3)

Participants The patient's CORMB score is 0 to 2

Participants The patient's CORMB score is 0 to 2

Diagnostic Test: Medical observation

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)

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

Interventions

Medical observation DIAGNOSTIC_TEST

Likely suitable for home treatment

Participants The patient's CORMB score is 0 to 2

Supportive treatment (BSC) DIAGNOSTIC_TEST

Consider hospital supervised treatment

Participants The patient's CORMB score is 3 to 4

Intensive care management DIAGNOSTIC_TEST

Manage in hospital as severe pneumonia

Participants The patient's CORMB score is 5 or above

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

The 900th Hospital of the Joint Logistic Support Force, PLA

Fuzhou, Fujian, 350000, China

RECRUITING

Related Publications (8)

• Ledford H. How severe are Omicron infections? Nature. 2021 Dec;600(7890):577-578. doi: 10.1038/d41586-021-03794-8. No abstract available.

  PMID: 34934198 RESULT

• Burki TK. Omicron variant and booster COVID-19 vaccines. Lancet Respir Med. 2022 Feb;10(2):e17. doi: 10.1016/S2213-2600(21)00559-2. Epub 2021 Dec 17. No abstract available.

  PMID: 34929158 RESULT

• Kupferschmidt K. Where did 'weird' Omicron come from? Science. 2021 Dec 3;374(6572):1179. doi: 10.1126/science.acx9738. Epub 2021 Dec 2. No abstract available.

  PMID: 34855502 RESULT

• Li Q, Nie J, Wu J, Zhang L, Ding R, Wang H, Zhang Y, Li T, Liu S, Zhang M, Zhao C, Liu H, Nie L, Qin H, Wang M, Lu Q, Li X, Liu J, Liang H, Shi Y, Shen Y, Xie L, Zhang L, Qu X, Xu W, Huang W, Wang Y. SARS-CoV-2 501Y.V2 variants lack higher infectivity but do have immune escape. Cell. 2021 Apr 29;184(9):2362-2371.e9. doi: 10.1016/j.cell.2021.02.042. Epub 2021 Feb 23.

  PMID: 33735608 RESULT

• Garcia-Beltran WF, Lam EC, St Denis K, Nitido AD, Garcia ZH, Hauser BM, Feldman J, Pavlovic MN, Gregory DJ, Poznansky MC, Sigal A, Schmidt AG, Iafrate AJ, Naranbhai V, Balazs AB. Multiple SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity. Cell. 2021 Apr 29;184(9):2372-2383.e9. doi: 10.1016/j.cell.2021.03.013. Epub 2021 Mar 12.

  PMID: 33743213 RESULT

• Cao Y, Yisimayi A, Bai Y, Huang W, Li X, Zhang Z, Yuan T, An R, Wang J, Xiao T, Du S, Ma W, Song L, Li Y, Li X, Song W, Wu J, Liu S, Li X, Zhang Y, Su B, Guo X, Wei Y, Gao C, Zhang N, Zhang Y, Dou Y, Xu X, Shi R, Lu B, Jin R, Ma Y, Qin C, Wang Y, Feng Y, Xiao J, Xie XS. Humoral immune response to circulating SARS-CoV-2 variants elicited by inactivated and RBD-subunit vaccines. Cell Res. 2021 Jul;31(7):732-741. doi: 10.1038/s41422-021-00514-9. Epub 2021 May 21.

  PMID: 34021265 RESULT

• Pulliam JRC, van Schalkwyk C, Govender N, von Gottberg A, Cohen C, Groome MJ, Dushoff J, Mlisana K, Moultrie H. Increased risk of SARS-CoV-2 reinfection associated with emergence of Omicron in South Africa. Science. 2022 May 6;376(6593):eabn4947. doi: 10.1126/science.abn4947. Epub 2022 May 6.

  PMID: 35289632 RESULT

• Zhang X, Wu S, Wu B, Yang Q, Chen A, Li Y, Zhang Y, Pan T, Zhang H, He X. SARS-CoV-2 Omicron strain exhibits potent capabilities for immune evasion and viral entrance. Signal Transduct Target Ther. 2021 Dec 17;6(1):430. doi: 10.1038/s41392-021-00852-5. No abstract available.

  PMID: 34921135 RESULT

MeSH Terms

Conditions

COVID-19; Infections; Suicide, Assisted

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• zongyang yu, Ph.D

  The 900th Hospital of the Joint Logistic Support Force, PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zongyang yu, Ph.D

CONTACT

13509327806; yuzy527@sina.com

jinhe xu, doctor

CONTACT

15705967557; 1436755231@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 10, 2023
• Study Start: January 4, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)