Defining COVID-19 Infection Severity on Presentation to Hospital

NCT ID: NCT05677789

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-04

Study Completion Date

2023-12-31

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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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.

Conditions

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COVID-19 Infections Morality Death, Assisted

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants The patient's CORMB score is 0 to 2

Participants The patient's CORMB score is 0 to 2

Medical observation

Intervention Type DIAGNOSTIC_TEST

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

Supportive treatment (BSC)

Intervention Type DIAGNOSTIC_TEST

Consider hospital supervised treatment

Participants The patient's CORMB score is 5 or above

Participants The patient's CORMB score is 5 or above

Intensive care management

Intervention Type DIAGNOSTIC_TEST

Manage in hospital as severe pneumonia

Interventions

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Medical observation

Likely suitable for home treatment

Intervention Type DIAGNOSTIC_TEST

Supportive treatment (BSC)

Consider hospital supervised treatment

Intervention Type DIAGNOSTIC_TEST

Intensive care management

Manage in hospital as severe pneumonia

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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zongyang yu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zongyang yu, Ph.D

Role: CONTACT

13509327806 ext. 22859650

jinhe xu, doctor

Role: CONTACT

15705967557 ext. 22859650

Facility Contacts

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zongyang yu, Ph.D

Role: primary

13509327806

jinhe xu, doctor

Role: backup

15705967557

References

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

Reference Type RESULT
PMID: 34934198 (View on PubMed)

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.

Reference Type RESULT
PMID: 34929158 (View on PubMed)

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.

Reference Type RESULT
PMID: 34855502 (View on PubMed)

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.

Reference Type RESULT
PMID: 33735608 (View on PubMed)

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.

Reference Type RESULT
PMID: 33743213 (View on PubMed)

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.

Reference Type RESULT
PMID: 34021265 (View on PubMed)

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.

Reference Type RESULT
PMID: 35289632 (View on PubMed)

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.

Reference Type RESULT
PMID: 34921135 (View on PubMed)

Other Identifiers

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CORMB-65

Identifier Type: -

Identifier Source: org_study_id

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