UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044291 |
|---|---|
| Receipt number | R000050592 |
| Scientific Title | A Clinical Trial on the Physical and Mental Effects of COVID-19 vaccination in Patients with Chronic Respiratory Failure. |
| Date of disclosure of the study information | 2021/05/22 |
| Last modified on | 2023/11/23 18:40:44 |
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Basic information
Public title
A Clinical Trial on the Physical and Mental Effects of COVID-19 vaccination in Patients with Chronic Respiratory Failure.
Acronym
Effects of a COVID-19 vaccination on patients with chronic respiratory failure.
Scientific Title
A Clinical Trial on the Physical and Mental Effects of COVID-19 vaccination in Patients with Chronic Respiratory Failure.
Scientific Title:Acronym
Effects of a COVID-19 vaccination on patients with chronic respiratory failure.
Region
| Japan |
Condition
Condition
Chronic Respiratory Failure
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The COVID-19 vaccine will be used to evaluate the presence and severity of adverse reactions to vaccination in patients with chronic respiratory failure and their relationship to background factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vital signs such as temperature, pulse, blood pressure, respiratory rate, and SpO2, subjective symptoms (drowsiness, lightheadedness, calmness, comfort, breathlessness, lethargy, headache, feverishness, inoculation site pain, and general pain) assessed by 100mm VAS, inoculation site reaction, systemic reaction, suspected adverse reaction, and serious adverse events
Key secondary outcomes
Confirmation of COVID-19 incidence at 4 weeks after the last vaccination, background factors such as underlying disease, age, gender, lung function, arterial blood gas, oxygen prescription volume, and NPPV prescription status and content of the vaccines
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
Patients diagnosed with chronic respiratory failure and receiving oxygen therapy or artificial respiration therapy
Key exclusion criteria
Patients with a poor prognosis, serious general condition, or other patients judged inappropriate by the physician.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Sumi |
Organization
National Hospital Organization Minami Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
6100113
Address
11 Naka Ashihara, Joyo City, Kyoto Prefecture
TEL
0774520065
kensukesumi@gmail.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Sumi |
Organization
National Hospital Organization Minami Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
6100113
Address
11 Naka Ashihara, Joyo City, Kyoto Prefecture
TEL
0774520065
Homepage URL
kensukesumi@gmail.com
Sponsor or person
Institute
National Hospital Organization Minami Kyoto Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Minami Kyoto Hospital
Address
11 Naka Ashihara, Joyo City, Kyoto Prefecture
Tel
0774520065
kensukesumi@gmail.com
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 | 05 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.jrs.or.jp/search/abstract/entry.php?id=30458
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jrs.or.jp/search/abstract/entry.php?id=30458
Number of participants that the trial has enrolled
101
Results
The mean CRP of 101 patients increased significantly from 0.66 to 0.91 before and after the first vaccination, and from 0.74 to 0.97 after the second vaccination. However, only 3 of 101 patients developed a fever of 38 degrees centigrade or higher after vaccination, and respiratory and circulatory status was not significantly affected.
Results date posted
| 2023 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
chronic respiratory failure
Participant flow
Vital signs and systemic symptoms of 101 patients with chronic respiratory failure up to 4 days after vaccination with the novel coronavirus vaccine. Vital signs, systemic symptoms, and various other adverse reactions were observed up to 4 days after vaccination.
Adverse events
none
Outcome measures
Vital signs, systemic symptoms
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 24 | 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 | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050592
| 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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