UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045053 |
|---|---|
| Receipt number | R000051463 |
| Scientific Title | Observational study of various blood parameters in Long COVID patients. |
| Date of disclosure of the study information | 2021/08/04 |
| Last modified on | 2022/08/03 09:33:59 |
* 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
Observational study of various blood parameters in Long COVID patients.
Acronym
Observational study of various blood parameters in Long COVID patients.
Scientific Title
Observational study of various blood parameters in Long COVID patients.
Scientific Title:Acronym
Observational study of various blood parameters in Long COVID patients.
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the relationship between indefinite complaints and various blood parameters in COVID-19 after-effects patients.
Basic objectives2
Others
Basic objectives -Others
Clarify the relationship between indefinite complaints and various blood parameters in COVID-19 after-effects patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Blood test
1-1.Plasma GSH,GSSG,low molecular weight thiol-bound GSH
1-2.Plasma malondialdehyde
1-3.Serum IL-6,TNF,IL-10
1-4.Peripheral blood including leukocyte image,AST,ALT,LDL,HDL,TG,FFA,BUN,creatinine,eGFR,Mg,Zn,Fe,ferritin,blood glucose,HbA1C,cortisol,25OHVD,vitamin C,high-sensitivity CRP,D Dimer
2.Questionnaire
COVID-19 history,medical history,current medical history,family history,life history,indefinite complaints,etc.
Key secondary outcomes
3.General measurements
age,gender,height,weight,BMI,etc.
4.Vital signs
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese males and females aged 20 to 49 years old
2)Confirmed infection with COVID-19.
3)Those who have received a full explanation of the purpose and content of the study,are capable of consenting,understand the study well,and have voluntarily volunteered to participate in the study and have agreed to participate in the study in writing.
Key exclusion criteria
1)Those who have a current or previous serious disease such as brain disease,malignant tumor,immunological disease,diabetes,liver disease hepatitis,renal disease,heart disease,etc.,thyroid disease,adrenal disease,or other metabolic disease
2)Those who have donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of consent.
3)Those who have difficulty in complying with the recording of various questionnaires.
4)Others who are judged as unsuitable as subjects by the principal investigator or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hirahata |
Organization
Hirahata Clinic
Division name
director
Zip code
150-0002
Address
Matrix 2 building 9F,1-24-6 Shibuya,Shibuya-ku,Tokyo
TEL
03-3400-3288
koichi.hirahata@gmail.com
Public contact
Name of contact person
| 1st name | Toyoshi |
| Middle name | |
| Last name | Urakami |
Organization
Mitsubishi Corporation Life Sciences Limited
Division name
Domestic Sales Group Nutrition Business Division
Zip code
100-0006
Address
1-2-2,Yurakucho,Chiyoda-ku,Tokyo
TEL
03-5501-7335
Homepage URL
toyoshi.urakami@mcls-ltd.com
Sponsor or person
Institute
Hirahata Clinic
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
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
C&C ethics committee
Address
8-3-16,Nishigotanda Sinagawa-Ku,Tokyo
Tel
03-6431-8761
nanbu@candc.co.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
医療法人社団創友会ヒラハタクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 04 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clarify the relationship between indefinite complaints and various blood parameters in COVID-19 after-effects patients.
Management information
Registered date
| 2021 | Year | 08 | Month | 03 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051463
