Defining COVID-19 Infection Severity on Presentation to Hospital

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677789
• Other study ID #: CORMB-65
• Status: Recruiting
• Start date: January 4, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Fuzhou General Hospital
• Contact: zongyang yu, Ph.D
• Phone: 13509327806
• Email: yuzy527[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 de?ciency 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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Morality
• Suicide, Assisted

Intervention

Diagnostic Test:
• Medical observation
Likely suitable for home treatment
• Supportive treatment (BSC)
Consider hospital supervised treatment
• Intensive care management
Manage in hospital as severe pneumonia

Locations

Country	Name	City	State
China	The 900th Hospital of the Joint Logistic Support Force, PLA	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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, — View Citation

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 humora — View Citation

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. — View Citation

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

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 — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality within 30days after diagnosis; Death from any cause	30days
Primary	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	Time to sustained disappearance of clinical symptoms	Time to sustained disappearance of clinical symptoms	Up to 30 days
Secondary	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
Secondary	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
Secondary	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