UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048380 |
|---|---|
| Receipt number | R000055121 |
| Scientific Title | Resarch of the effect of antiviral drugs on the suppression of COVID-19 persistent symptoms |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2025/01/15 09:48:40 |
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Basic information
Public title
Resarch of the effect of antiviral drugs on the suppression of COVID-19 persistent symptoms
Acronym
Resarch of the effect of antiviral drugs on the suppression of COVID-19 persistent symptoms
Scientific Title
Resarch of the effect of antiviral drugs on the suppression of COVID-19 persistent symptoms
Scientific Title:Acronym
Resarch of the effect of antiviral drugs on the suppression of COVID-19 persistent symptoms
Region
| Japan |
Condition
Condition
COVID-19
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients diagnosed with mild COVID-19 in the Outpatient setting will be compared between no treatment and monnupilavir, no treatment and nilmatrelvir/ritonavir, and no treatment and encitrelvir at 12 weeks after presentation, with the development of persistent symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Development of COVID-19 persistent symptoms at 12 weeks after first visit
Key secondary outcomes
Development of COVID-19 persistent symptoms at 28 days, 24 weeks, 36 weeks, and 48 weeks after first visit
Comparison of patient background (age, days of disease onset, number of SARS-Cov-2 vaccinations, risk of COVID-19 severity) in each group
Search for predictive factors for the development of COVID-19 persistent symptoms using blood samples
Hospitalization rate within 28 days of first visit
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
(1) Patients who visited Nagasaki University Hospital or collaborating hospitals for COVID-19 and were diagnosed with mild COVID-19 between the date of research approval by the director of the institution and December 31, 2022.
(2) Patients who were followed up without treatment in an outpatient clinic after the diagnosis of mild COVID-19
(3) Patients who were prescribed antiviral drugs as outpatients after the diagnosis of mild COVID-19
(4) Age: 18 years and older
(5) Patients who are able to respond to questionnaires via the Internet
(6) Patients who have received a full explanation of their participation in this study, and who have given their voluntary consent based on a good understanding of the study
Key exclusion criteria
(1) Patients diagnosed with moderate or severe COVID-19 at the time of first visit
(2) Patients diagnosed with COVID-19 during hospitalization
(3) Patients with COVID-19 who were started on antiviral drugs during hospitalization
(4) Other patients deemed inappropriate as research subjects by the investigators.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Takazono |
Organization
Nagasaki University Graduate school of Biomedical Sciensse
Division name
department of infectious diseases
Zip code
852-8501
Address
Department of Second Internal Medicine, Nagasaki University Hospital 9F, 1-7-1 Sakamoto, Nagasaki City, Nagasaki
TEL
095-819-7273
takahiro-takazono@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Takazono |
Organization
Nagasaki University Graduate school of Biomedical Sciensse
Division name
department of infectious diseases
Zip code
852-8501
Address
Department of Second Internal Medicine, Nagasaki University Hospital , 1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7273
Homepage URL
takahiro-takazono@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Graduate school of Biomedical Sciensse department of infectious diseases
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.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
長崎大学病院（長崎県）
長崎みなとメディカルセンター（長崎県）
長崎済生会病院（長崎県）
佐世保市総合医療センター（長崎県）
佐世保中央病院（長崎県）
宮崎大学病院（宮崎県）
宮崎東病院（宮崎県）
大分大学病院（大分県）
福岡大学筑紫病院（福岡県）
産業医科大学病院（福岡県）
産業医科大学若松病院（福岡県）
霧が丘つだ病院（福岡県）
くらて病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 15 | 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
382
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
| 2022 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
We have finished enrolling cases and are conducting the analysis.
Management information
Registered date
| 2022 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055121
