UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053506 |
|---|---|
| Receipt number | R000060919 |
| Scientific Title | Prospective observational study of COVID-19 patients in the TOKUSHUKAI GROUP |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/04/15 14:35:23 |
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Basic information
Public title
Prospective observational study of COVID-19 patients in the TOKUSHUKAI GROUP
Acronym
ANCHOR Study
Scientific Title
Prospective observational study of COVID-19 patients in the TOKUSHUKAI GROUP
Scientific Title:Acronym
ANCHOR Study
Region
| Japan |
Condition
Condition
The purpose of this study is to collect information of the clinical course of patients with COVID-19 treated at Tokushukai hospitals with and without antiviral drugs and to explore the clinical course in the acute phase, the frequency of severe disease, and frequency of post COVID-19 condition by the treatment, after adjusting by patient background including risk factor(s) and symptoms at the time of registration.
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect information of the clinical course of patients with COVID-19 treated at Tokushukai hospitals with and without antiviral drugs and to explore the clinical course in the acute phase, the frequency of severe disease, and frequency of post COVID-19 condition by the treatment, after adjusting by patient background including risk factor(s) and symptoms at the time of registration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All patients
Subject background
Adherence of anti SARS CoV2 drug
Incidence of post COVID 19 condition
Incidence of severe disease
Frequency of hospital re visit for COVID 19
Administration of antimicrobial agents
Change from baseline in work productivity score
Change in score of support and care required
Adverse events of anti SARS CoV 2 drugs
Inpatients only
Time to alleviation of each COVID 19 symptom
Time to alleviation of COVID 19 symptoms (all 14 symptoms)
Time to resolution of fever
Key secondary outcomes
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible.
1) Patients with SARS-CoV-2 infection with symptoms and diagnosed as COVID-19 at Tokushukai Hospitals
2)Patients who have given informed consent/assent in writing of their own free will to participate in this study (including their parental consent in case of patients are under 18 years of age at the time of consent)
3)Male and Female aged 12 years or older at the time of informed consent
Key exclusion criteria
Patients who meet at least one of the following criteria are excluded.
1) Patients who received anti-SARS-Cov-2 drugs within 30 days prior to registration.
2) Patients who have previously participated in this study.
3) Patients who are currently participating in a clinical trial or an interventional prospective study. (Excluding minor interventions)
4) Patients who have not passed 150 days since the last dose of investigational study drug or unapproved drug.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan-Fujisawa Tokushukai Hospital
Division name
Pulmonology
Zip code
251-0041
Address
1-5-1 Tsujidokandai Fujisawa-Shi Kanagawa Japan
TEL
0466-35-1177
makotohibino560328@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kinoshita |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
541-0045
Address
3-1-8 Doshomachi, Osaka Chuo-ku, Osaka, Japan
TEL
06-6202-2161
Homepage URL
Masahiro.Kinoshita@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
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
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
homepage@tokushukai.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
| 2024 | Year | 02 | Month | 01 | 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
| 2023 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060919
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
