Defining COVID-19 Infection Severity on Presentation to Hospital
NCT ID: NCT05677789
Last Updated: 2023-01-10
Study Results
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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UNKNOWN
3000 participants
OBSERVATIONAL
2023-01-04
2023-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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)
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
Manage in hospital as severe pneumonia
Interventions
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Medical observation
Likely suitable for home treatment
Supportive treatment (BSC)
Consider hospital supervised treatment
Intensive care management
Manage in hospital as severe pneumonia
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Fuzhou General Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CORMB-65
Identifier Type: -
Identifier Source: org_study_id
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