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 | 2025/07/16 12:24:42 |
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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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
382
Results
Of the included 246 cases, 76 (35.5%) experienced at least one long COVID symptom 12 weeks after onset. Logistic regression analysis revealed that age over 40 years was significantly associated with an increased risk of respiratory (odds ratio [OR]: 3.80, 95% confidence interval [CI]: 1.67-8.65) and neurologic symptoms (OR: 4.53, 95% CI: 1.84-11.13). Conversely, antiviral drug use was associated with a decreased risk of respiratory symptoms (OR: 0.31, 95% CI: 0.11-0.93).
Results date posted
| 2025 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 05 | Day |
Baseline Characteristics
Of the 246 cases at 4 weeks after onset, 173 cases (70.3%) were female, with a median age of 39.5 years. This indicated that the study predominantly included younger-to-middle-aged women. Among the included cases, 232 (94.3%) were vaccinated at least twice, and 49 (19.9%) had at least one risk factor for severe COVID-19. Regarding antiviral drug use in 51 (20.7%) cases, 23 were treated with nirumatrelvir/ritonavir, 19 with molnupiravir, and 9 with ensitrelvir.
Participant flow
Of the 322 mild COVID-19 patients who provided consent, 312 met the inclusion criteria (Figure 1). There were no patients hospitalized with severe COVID-19. The response rate among patients who completed the questionnaire was 78.8% at 4 weeks post-onset, 68.6% at 12 weeks, and 64.1% at 24 weeks. After excluding non-respondents and delayed responses, the final analysis included 246 cases at 4 weeks post-onset, 214 cases at 12 weeks, and 200 cases at 24 weeks.
Adverse events
None
Outcome measures
A total of 76 (35.5%) cases reported the persistence of one or more symptoms at 12 weeks after onset, including fatigue (15.0%), cough (14.0%), and memory impairment (14.5%). Although the number of cases with long COVID decreased over time, 50 (25.0%) cases continued to experience symptoms at 24 weeks after onset.
Multivariate analysis for variables with higher ORs and antiviral drug use demonstrated that age over 40 years was associated with an increased risk of respiratory symptoms 12 weeks after onset (OR: 3.80, 95% CI: 1.67-8.65), whereas antiviral drug treatment was associated with a decreased risk (OR: 0.31, 95% CI: 0.11-0.93). Conversely, antiviral drug use did not reduce the risk of other long COVID symptoms 12 weeks after onset. Moreover, diabetes mellitus was significantly associated with fatigue on univariate and multivariate analyses (OR: 5.09, 95% CI: 1.02-25.43), and age over 40 years was significantly associated with neurological symptoms on univariate and multivariate analyses (OR: 4.53, 95% CI: 1.84-11.13).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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 the analysis.
The results of this study were published in Respir Investig. 2025 May;63(3):303-310.
Management information
Registered date
| 2022 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055121
