UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044927 |
|---|---|
| Receipt number | R000051317 |
| Scientific Title | General Drug Use Surveillance of RONAPREVE injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset - |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2022/12/28 06:57:46 |
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Basic information
Public title
General Drug Use Surveillance of RONAPREVE
injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset -
Acronym
General Drug Use Surveillance of RONAPREVE
injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset -
Scientific Title
General Drug Use Surveillance of RONAPREVE
injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset -
Scientific Title:Acronym
General Drug Use Surveillance of RONAPREVE
injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination])- SARS-CoV-2 infection or prevention of onset -
Region
| Japan |
Condition
Condition
SARS-CoV-2 infection. Prevention of SARS-CoV-2 infection.
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the incidence of severe hypersensitivity (e.g. anaphylaxis) and infusion reactions during the use of RONAPREVE injection set (casirivimab [genetical recombination] and imdevimab [genetical recombination]) (hereinafter, RONAPREVE) for SARS-CoV-2 infection or prevention of onset, because of limited information on the use of RONAPREVE in the Japanese population before approval.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary surveillance items, etc.
1)Institution information
Name of institution, name of department, name of physician
2)Patient demographics
Patient initials, sex, (Yes/No) pregnancy, (Yes/No) breastfeeding, ID number, age at treatment initiation, medical treatment classification, reason for use, risk factors for severe disease, previous disease, concurrent disease, smoking history, allergy history, COVID-19 vaccine history, mutant strain test.
Only for SARS-CoV-2 infection: Seriousness before treatment, clinical manifestations at treatment initiation, respiratory care at treatment initiation, oxygen saturation (SpO2) at treatment initiation, date of onset (first symptoms noticed)
3)Only for SARS-CoV-2 infection: (Yes/No) previous treatments and if yes: name of previous treatment
4)RONAPREVE treatment status
Route of administration, dose per administration, administration site (only for subcutaneous injection), administration time (only for intravenous injection), administration date
5)Only for SARS-CoV-2 infection: Outcome of SARS-CoV-2 infection, outcome
6)Only for prevention of SARS-CoV-2 infection: (Yes/No) onset of SARS-CoV-2 infection, date of last observation or onset
7)Concomitant treatments
(Yes/No) and if yes: name of treatment, treatment start date, treatment stop date
8)Adverse events
(Yes/No) and if yes: adverse event name, date of onset, seriousness, worst grade, action taken (for RONAPREVE, other), outcome, date of outcome, causal relationship (with RONAPREVE, other factors)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases eligible for enrollment: Cases with SARS-CoV-2 infection or at risk who are expected to receive RONAPREVE for the first time during the enrollment period at surveillance-contracted institutions.
Cases eligible for case report form (CRF) collection: All cases eligible for enrollment who receive RONAPREVE.
Key exclusion criteria
None
Target sample size
770
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nomura |
Organization
Chugai Pharmaceutical Co. Ltd
Division name
Safety science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
nomuramkt@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ryousue |
| Middle name | |
| Last name | Harada |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
haradarus@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical 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
None
Address
None
Tel
None
None
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 | 08 | Month | 31 | 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 | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2021 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051317
