Unique ID issued by UMIN | UMIN000044291 |
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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 |
A Clinical Trial on the Physical and Mental Effects of COVID-19 vaccination in Patients with Chronic Respiratory Failure.
Effects of a COVID-19 vaccination on patients with chronic respiratory failure.
A Clinical Trial on the Physical and Mental Effects of COVID-19 vaccination in Patients with Chronic Respiratory Failure.
Effects of a COVID-19 vaccination on patients with chronic respiratory failure.
Japan |
Chronic Respiratory Failure
Pneumology |
Others
NO
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.
Safety,Efficacy
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
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
Observational
Not applicable |
Not applicable |
Male and Female
Patients diagnosed with chronic respiratory failure and receiving oxygen therapy or artificial respiration therapy
Patients with a poor prognosis, serious general condition, or other patients judged inappropriate by the physician.
120
1st name | Kensuke |
Middle name | |
Last name | Sumi |
National Hospital Organization Minami Kyoto Hospital
Department of Respiratory Medicine
6100113
11 Naka Ashihara, Joyo City, Kyoto Prefecture
0774520065
kensukesumi@gmail.com
1st name | Kensuke |
Middle name | |
Last name | Sumi |
National Hospital Organization Minami Kyoto Hospital
Department of Respiratory Medicine
6100113
11 Naka Ashihara, Joyo City, Kyoto Prefecture
0774520065
kensukesumi@gmail.com
National Hospital Organization Minami Kyoto Hospital
none
Other
National Hospital Organization Minami Kyoto Hospital
11 Naka Ashihara, Joyo City, Kyoto Prefecture
0774520065
kensukesumi@gmail.com
NO
2021 | Year | 05 | Month | 22 | Day |
https://www.jrs.or.jp/search/abstract/entry.php?id=30458
Unpublished
https://www.jrs.or.jp/search/abstract/entry.php?id=30458
101
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.
2023 | Year | 05 | Month | 27 | Day |
chronic respiratory failure
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.
none
Vital signs, systemic symptoms
Completed
2021 | Year | 05 | Month | 22 | Day |
2021 | Year | 04 | Month | 14 | Day |
2021 | Year | 05 | Month | 24 | Day |
2022 | Year | 05 | Month | 24 | Day |
none
2021 | Year | 05 | Month | 22 | Day |
2023 | Year | 11 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050592
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