UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045358 |
|---|---|
| Receipt number | R000051784 |
| Scientific Title | The effect of casirivimab with imdevimab on disease progression in nonsevere COVID-19 patients in a single hospital in Japan. |
| Date of disclosure of the study information | 2021/09/02 |
| Last modified on | 2023/10/14 19:36:37 |
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Basic information
Public title
The effect of casirivimab with imdevimab on disease progression in nonsevere COVID-19 patients in a single hospital in Japan.
Acronym
The effect of casirivimab with imdevimab on disease progression in nonsevere COVID-19 patients in a single hospital in Japan.
Scientific Title
The effect of casirivimab with imdevimab on disease progression in nonsevere COVID-19 patients in a single hospital in Japan.
Scientific Title:Acronym
The effect of casirivimab with imdevimab on disease progression in nonsevere COVID-19 patients in a single hospital in Japan.
Region
| Japan |
Condition
Condition
Infectious disease
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of neutralizing monoclonal antibodies on clinical outcomes for COVID-19 patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Disease progression to severe COVID-19. Severe COVID-19 is defined as patients requiring oxygen therapy and dexamethasone.
(2) Composite outcome that includes critical care needs and in-hospital death.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who meet all the following criteria will be eligible.
(1)The patient age is 18 years old.
(2)COVID-19 is diagnosed based on nucleic acid tests or antigen tests.
(3)The duration of COVID-19 symptoms is less than 7 days.
(4)The patient has at least one risk factor.
(5)Fever associated with COVID-19 is documented within 24 hours before admission or during hospitalization.
Key exclusion criteria
Patients whose symptoms started more than 14 days after the second COVID-19 vaccination were excluded. Patients who required oxygen therapy due to persistent hypoxia at admission were also excluded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Internal Medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL
028-622-5241
jkomagamine@tochigi-mc.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Komagamine |
Organization
National Hospital Organization Tochigi Medical Center
Division name
Internal Medicine
Zip code
3208580
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
TEL
028-622-5241
Homepage URL
jkomagamine@tochigi-mc.jp
Sponsor or person
Institute
National Hospital Organization Tochigi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tochigi Medical Center
Address
1-10-37, Nakatomatsuri, Utsunomiya, Tochigi
Tel
028-622-5241
atamura@tochigi-mc.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 | 02 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single-center observational study will be conducted by using electronic medical records. Data from July 20, 2021 to January 31, 2022 will be used. Consecutive nonsevere febrile COVID-19 patients with symptoms of COVID-19 within 7 days and at least one risk factor will be included. The primary outcomes are progression to severe COVID-19, which required oxygen supplementation and dexamethasone and a composite outcome that includes critical care needs and in-hospital death. Patients who are treated with casirivimab with imdevimab are compared with those who are provided standard care (control group) for the primary outcomes.
Management information
Registered date
| 2021 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051784
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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