COVID-19NCT05677789
Defining COVID-19 Infection Severity on Presentation to Hospital
An observational study of COVID-19 and Infections, run by Fuzhou General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Infections, Morality
- What is being tested?
- Medical observation, Supportive treatment (BSC) and Intensive care management
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2023to 31 Dec 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 900th Hospital of the Joint Logistic Support Force, PLA
Fuzhou, Fujian, 350000
zongyang yu, Ph.D, 13509327806, yuzy527@sina.com
jinhe xu, doctor, 15705967557, 1436755231@qq.com
About this study
Official title: 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.
Read the detailed description
- Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
- The following is the general sequence of events during the 30-day evaluation period:
- Completion of baseline procedures Participants were assessed for 30 days and completed all safety monitoring.
- Conditions
- COVID-19, Infections, Morality, Death, Assisted
- Being tested
- Medical observation, Supportive treatment (BSC), Intensive care management
- Medical subject headings
- COVID-19, Infections, Suicide, Assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical observationDiagnostic test
Likely suitable for home treatment
Supportive treatment (BSC)Diagnostic test
Consider hospital supervised treatment
Intensive care managementDiagnostic test
Manage in hospital as severe pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Participants The patient's CORMB score is 0 to 2 | Participants The patient's CORMB score is 0 to 2 Receives: Diagnostic Test: Medical observation | |
| Participants The patient's CORMB score is 3 to 4 | Participants The patient's CORMB score is 3 to 4 Receives: 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 Receives: Diagnostic Test: Intensive care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality within 30days after diagnosis; Death from any cause
Measured: 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
Measured: Day 1 to 30 days
Secondary outcomes (4)
Time to sustained disappearance of clinical symptoms
Time to sustained disappearance of clinical symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start4 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zongyang yu, Ph.D, Principal investigator, The 900th Hospital of the Joint Logistic Support Force, PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677789
- Sponsor's protocol ID
- CORMB-65
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34934198Burki 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.
PubMed 34929158Kupferschmidt 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.
PubMed 34855502Li 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.
PubMed 33735608Garcia-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.
PubMed 33743213Cao 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.
PubMed 34021265Pulliam 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.
PubMed 35289632Zhang 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.
PubMed 34921135
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining COVID-19 Infection Severity on Presentation to Hospital: a Multicentre Prospective Study
- ClinicalTrials.gov ID
- NCT05677789
- Acronym / sponsor ID
- CORMB-65
- Conditions
- COVID-19, Infections, Morality, Death, Assisted
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
- The following is the general sequence of events during the 30-day evaluation period:
- Completion of baseline procedures Participants were assessed for 30 days and completed all safety monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants The patient's CORMB score is 0 to 2 | – | Diagnostic Test: Medical observationParticipants The patient's CORMB score is 0 to 2 |
| Participants The patient's CORMB score is 3 to 4 | – | Diagnostic Test: Supportive treatment (BSC)Participants The patient's CORMB score is 3 to 4 |
| Participants The patient's CORMB score is 5 or above | – | Diagnostic Test: Intensive care managementParticipants The patient's CORMB score is 5 or above |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical observationLikely suitable for home treatment | Diagnostic test | Participants The patient's CORMB score is 0 to 2 |
| Supportive treatment (BSC)Consider hospital supervised treatment | Diagnostic test | Participants The patient's CORMB score is 3 to 4 |
| Intensive care managementManage in hospital as severe pneumonia | Diagnostic test | Participants The patient's CORMB score is 5 or above |
Primary outcome
Mortality
Time frame: 30days
Mortality within 30days after diagnosis; Death from any cause
Deterioration of the condition
Time frame: Day 1 to 30 days
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
4 secondary outcomes
Time to sustained disappearance of clinical symptoms
Time frame: Up to 30 days
Percentage of participants with no clinical symptom
Time frame: Day 3, 5, 7, 10, 14, 21 and 28
Percentage of participants who turned negative for SARS-CoV-2 and/or COVID-19 antigen
Time frame: Day 3, 5, 7, 10, 14, 28
Safety assessment Results: such as AEs and SAEs through Day 30
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Results publication: PubMed 34934198Ledford H. How severe are Omicron infections? Nature. 2021 Dec;600(7890):577-578. doi: 10.1038/d41586-021-03794-8. No abstract available.
- Results publication: PubMed 34929158Burki 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.
- Results publication: PubMed 34855502Kupferschmidt 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.
- Results publication: PubMed 33735608Li 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.
- Results publication: PubMed 33743213Garcia-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.
- Results publication: PubMed 34021265Cao 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.
- Results publication: PubMed 35289632Pulliam 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.
- Results publication: PubMed 34921135Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zongyang yu, Ph.D principal investigator
The 900th Hospital of the Joint Logistic Support Force, PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Infections, run by Fuzhou General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zongyang yu, Ph.D (13509327806 ext. 22859650, yuzy527@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677789, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.