UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052703 |
|---|---|
| Receipt number | R000060141 |
| Scientific Title | A registry study on the actual situation for COVID-19 outpatients in Japan -ANTARES STUDY- |
| Date of disclosure of the study information | 2023/11/08 |
| Last modified on | 2025/10/21 19:13:11 |
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Basic information
Public title
A registry study on the actual situation for COVID-19 outpatients in Japan -ANTARES STUDY-
Acronym
A registry study on the actual situation for COVID-19 outpatients in Japan -ANTARES STUDY-
Scientific Title
A registry study on the actual situation for COVID-19 outpatients in Japan -ANTARES STUDY-
Scientific Title:Acronym
A registry study on the actual situation for COVID-19 outpatients in Japan -ANTARES STUDY-
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to collect information of treatment and clinical course in COVID-19 outpatients, and to assess clinical course in acute phase and to explore frequency and the risk factor of Post COVID-19 Condition in real world setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Subject background
-Drug adherence
-Time to resolution of each COVID-19 symptom
-Time to resolution of COVID-19 symptoms
-Time to fever resolution
-Frequency of Post COVID-19 Condition
-Change from baseline in Quality of Life(12-Item Short Form Health Survey)
-Change from baseline in work productivity score(Work Productivity and Activity Impairment Questionnaire)
-Frequency of severe COVID-19
-Frequency of return visit for COVID-19
-Frequency of secondary infection in family members
-Adverse events
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 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)
2) Male and Female aged 12 years or older at the time of informed consent
3) Patients who are diagnosed SARS-CoV-2 positive by Nucleic Acid Amplification test (PCR, LAMP, NEAR), Qualitative Antigen Test or Quantitative Antigen Test on the enrollment date by their principal (or sub-) investigator
4) Patents who are at high risk of severe disease or expected progression of symptoms at the date of enrollment, or patients without risk factors for severe disease with severe symptoms related to COVID-19 such as fever, sore throat and cough
5) Patients who are able to prepare a smartphone or tablet device and an environment to connect to the application in order to answer the questionnaire
Key exclusion criteria
Patients who meet at least one of the following criteria are excluded.
1) Patients who are judged by their principal (or sub-) investigator from each site to ineligible to participate in this study
2) Hospitalized patients or patients who are treated COVID-19 in hospital
3) Patients who received anti-SARS-Cov-2 drugs within 30 days prior to enrollment
4) Patients who receiving injectable anti-SARS-CoV-2 drugs, or drugs with reported effects on SARS-CoV-2 such as favipiravir and ivermectin at the date of enrollment (however, molnupiravir, nirmatrelvir/ ritonavir and ensitrelvir can be administered)
5) Patients who have previously participated in this study
6) Patients who are currently participating in clinical trials or interventional prospective studies, not limited to COVID-19 related study
7) Patients who have not received 30 days of the last dose or 5 times the half-life period of the investigational study drug or unapproved drug
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ohmagari |
Organization
National Center for Global Health and Medicine
Division name
Disease Control and Prevention Center
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
TEL
03-3202-7181
nohmagari@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Uemura |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
100-0005
Address
1-8-2 Marunouchi, Chiyoda-ku, Tokyo
TEL
06-6202-2161
Homepage URL
naomi.uemura@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
Center for Clinical Sciences of National Center for Global Health and Medicine
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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
| 2023 | Year | 11 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060141
