UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045462 |
|---|---|
| Receipt number | R000051793 |
| Scientific Title | Predicting Deterioration of COVID-19 using Biomarkers |
| Date of disclosure of the study information | 2021/09/15 |
| Last modified on | 2022/03/14 12:57:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Predicting Deterioration of COVID-19 using Biomarkers
Acronym
PreCOB study
Scientific Title
Predicting Deterioration of COVID-19 using Biomarkers
Scientific Title:Acronym
PreCOB study
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Laboratory medicine | Emergency medicine | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate whether biomarkers, including cytokines in blood, would predict the deterioration of mild to moderate COVID-19.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Newly initiated oxygen therapy by 14 days after admission
Key secondary outcomes
National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale and Japanese Ministry of Health, Labor, and Welfare severity classification of COVID-19 on Day 0,2,4,6,8,10,12,14, as well as on the day when oxygen therapy is initiated and the day when mechanical ventilation is initiated. In-hospital, 28-day, and 90-day mortality. Hospital-, ICU-, oxygen-, ventilator-, RRT-, and vasopressor-free days until Day 28 after admission. Tracheostomy and time when tracheostomy is performed. Organ failure score such as Sequential Organ Failure Assessment score (SOFA score) and Japanese Association for Acute Medicine disseminated intravascular coagulation criteria (JAAM DIC diagnostic criteria) on Day 0, 2, 7, 14 after admission.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)COVID-19 confirmed with SARS-CoV-2 PCR test
2)No oxygen requirement on hospital admission
Key exclusion criteria
1) hepatitis C
2) Rheumatoid arthritis and autoimmune diseases
3) Immunosuppressed patients
4) Patient who is expected to die within 48 hours after admission
5) Patient who is considered to be inappropriate for the inclusion to this study by a treating physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Homma |
Organization
School of Medicine, Keio University
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35, Shinano-machi, Shinjuku-ku, Tokyo
TEL
0332251323
homma@keio.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Kaito |
Organization
School of Medicine, Keio University
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35, Shinano-machi, Shinjuku-ku, Tokyo
TEL
0332251323
Homepage URL
hoobar55@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, School of Medicine, Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0353633503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the accuracy of predicting deterioration of COVID-19 (defined with the initiation of oxygen therapy, or by NIAID ordinal scale) by prospectively measured biomarkers (IFN-lambda3, IL-6, IL-10, IL-18, CXCL10, CCL17), AUROC will be calculated and compared. After adding biomarkers to the existed scale for the severity and/or deterioration, AUROC will be evaluated to exam whether the accuracy is improved. In addition, we will make several subgroups based on clinical information(age, gender, blood tests, imaging tests, treatment details, etc.) and the ability to predict the deterioration of COVID-19 will be evaluated.
Management information
Registered date
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051793
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
