COVID-19 PneumoniaNCT05047016
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY
A study testing Virtual investigational product in people with COVID-19 Pneumonia, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Virtual investigational product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 13 Sep 2021to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects who can use METORY (application platform)
- Subjects who completely understand the study and voluntarily decide to participate in the study
Who cannot join
- Subjects who are not able to use the web or application due to cognitive dysfunction or other reasons
- Subjects who are not able to measure body temperature by themselves
- Subjects who investigators decide not be appropriate for the study for other reasons
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: A Virtual Clinical Trial to Implement and Evaluate the Dynamic Consent Model Based on the Blockchain-based Next-generation Clinical Trial Platform METORY
Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial.
Read the detailed description
The study will simulate a clinical trial that implements dynamic consent module. In this study, two major and three minor protocol amendments will be conducted on the scheduled date. Each subjects will give consent using the dynamic consent platform, METORY, and will be informed when the protocol is amended. The communication only be conducted under the METORY and the real-world experience of METORY would be evaluated.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Virtual investigational product
- Keywords
- blockchain, dynamic consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual investigational productOther
The virtual investigational product is a predefined text (e.g. AB123F). By entering the code into the application, the virtual 'administration' of the IP is conducted.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic consent arm | Other | Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint. Receives: Other: Virtual investigational product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time
The time interval between notification of protocol amendment and subjects' response (consent)
Measured: Study Period of 4 weeks
Secondary outcomes (2)
Study completion rate
The proportion of subjects who completed the study
Measured: Study Period of 4 weeks
Dropout rate
The proportion of subjects who withdrew the study
Measured: Study Period of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start13 Sep 2021
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeungHwan Lee, Seoul National University Hospital
- Investigators
- SeungHwan Lee, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047016
- Sponsor's protocol ID
- METORY-101
- Status last verified
- Nov 2021
- First submitted
- 8 Sep 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Clinical Trial to Implement and Evaluate the Dynamic Consent Model Based on the Blockchain-based Next-generation Clinical Trial Platform METORY
- ClinicalTrials.gov ID
- NCT05047016
- Acronym / sponsor ID
- METORY-101
- Conditions
- COVID-19 Pneumonia
- Keywords
- blockchain, dynamic consent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial.
Detailed description
The study will simulate a clinical trial that implements dynamic consent module. In this study, two major and three minor protocol amendments will be conducted on the scheduled date. Each subjects will give consent using the dynamic consent platform, METORY, and will be informed when the protocol is amended. The communication only be conducted under the METORY and the real-world experience of METORY would be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic consent arm | Other | Other: Virtual investigational productSubjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who can use METORY (application platform)
- Subjects who completely understand the study and voluntarily decide to participate in the study
Key exclusion criteria (3 listed)
- Subjects who are not able to use the web or application due to cognitive dysfunction or other reasons
- Subjects who are not able to measure body temperature by themselves
- Subjects who investigators decide not be appropriate for the study for other reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual investigational productThe virtual investigational product is a predefined text (e.g. AB123F). By entering the code into the application, the virtual 'administration' of the IP is conducted. | Other | Dynamic consent arm |
Primary outcome
Response time
Time frame: Study Period of 4 weeks
The time interval between notification of protocol amendment and subjects' response (consent)
2 secondary outcomes
Study completion rate
Time frame: Study Period of 4 weeks
Dropout rate
Time frame: Study Period of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SeungHwan Lee, M.D., Ph.D. principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual investigational product in people with COVID-19 Pneumonia, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time (time frame: Study Period of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021; AzTrials last refreshed its copy on 30 Oct 2026.