Defining COVID-19 Infection Severity on Presentation to Hospital

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; COVID-19; Morality; Death, Assisted
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Zongyang Yu, Ph.D; Phone Number: 22859650 13509327806; Email: yuzy527@sina.com
• Study Contact Backup: Name: jinhe xu, doctor; Phone Number: 22859650 15705967557; Email: 1436755231@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • The 900th Hospital of the Joint Logistic Support Force, PLA
      • Contact: Zongyang Yu, Ph.D; Phone Number: 13509327806; Email: yuzy527@sina.com
      • Contact: jinhe xu, doctor; Phone Number: 15705967557; Email: 1436755231@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Supportive treatment (BSC); Consider hospital supervised treatment
Participants The patient's CORMB score is 5 or above	Diagnostic test: Intensive care management; Manage in hospital as severe pneumonia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to sustained disappearance of clinical symptoms	Time to sustained disappearance of clinical symptoms	Up to 30 days
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
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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. Erratum In: Cell. 2021 Apr 29;184(9):2523.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 7, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Self-Injurious Behavior; Suicide; COVID-19; Infections; Communicable Diseases; Suicide, Assisted
• Other Study ID Numbers: CORMB-65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No