Covid19Phase 3NCT04721535
A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
A Phase 3 study testing DWJ1248 in people with Covid19 and SARS-COV-2 Infection, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-COV-2 Infection
- What is being tested?
- DWJ1248
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jun 2021to 6 Oct 2021
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over the age of 19 as of the signed date in written consent
- Subjects in self-quarantine who contact from COVID-19 confirmed patient
- Subjects who have COVID-19 negative RT-PCR result
- Subjects with no symptoms of COVID-19
Who cannot join
- Subjects who cannot orally administer the investigational products
- Subjects who need administration of immunosuppressants
- Subjects who are allergic or sensitive to investigational products or its ingredients
- Subjects who have a history of drug and/or alcohol abuse within 12 months before screening
- Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.
- Conditions
- Covid19, SARS-COV-2 Infection
- Being tested
- DWJ1248, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1248Drug
Orally, 1 tablet of DWJ1248 TID, up to 14 days
PlaceboDrug
Orally, 1 tablet of placebo TID, up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| DWJ1248 | Experimental | Camostat mesilate 200mg Receives: Drug: DWJ1248 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with COVID-19
positive result in RT-PCR test
Measured: Up to 14 days
Secondary outcomes (2)
Percentage of subjects with hospitalization
hospitalization due to COVID-19
Measured: Days 3, 7, 14, and 28
Percentage of subjects who experience intensive care unit (ICU)
ICU requirement due to COVID-19
Measured: Days 3, 7, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start7 Jun 2021
- Primary completion23 Sep 2021
- Study completion6 Oct 2021
Why it stopped: Termination of study due to sponsor's internal decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721535
- Sponsor's protocol ID
- DW_DWJ1248303
- Status last verified
- Dec 2022
- First submitted
- 20 Jan 2021
- Last updated
- 7 Dec 2022
- Results posted
- 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 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
- ClinicalTrials.gov ID
- NCT04721535
- Acronym / sponsor ID
- DW_DWJ1248303
- Conditions
- Covid19, SARS-COV-2 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of study due to sponsor's internal decision
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 22 Jan 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.
To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ1248 | Experimental | Drug: DWJ1248Camostat mesilate 200mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over the age of 19 as of the signed date in written consent
- Subjects in self-quarantine who contact from COVID-19 confirmed patient
- Subjects who have COVID-19 negative RT-PCR result
- Subjects with no symptoms of COVID-19
Key exclusion criteria (5 listed)
- Subjects who cannot orally administer the investigational products
- Subjects who need administration of immunosuppressants
- Subjects who are allergic or sensitive to investigational products or its ingredients
- Subjects who have a history of drug and/or alcohol abuse within 12 months before screening
- Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
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 |
|---|---|---|
| DWJ1248Orally, 1 tablet of DWJ1248 TID, up to 14 days | Drug | DWJ1248 |
| PlaceboOrally, 1 tablet of placebo TID, up to 14 days | Drug | Placebo |
Primary outcome
Percentage of subjects with COVID-19
Time frame: Up to 14 days
positive result in RT-PCR test
2 secondary outcomes
Percentage of subjects with hospitalization
Time frame: Days 3, 7, 14, and 28
Percentage of subjects who experience intensive care unit (ICU)
Time frame: Days 3, 7, 14, and 28
Results and safety
The study was stopped early (reason given: Termination of study due to sponsor's internal decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWJ1248 in people with Covid19 and SARS-COV-2 Infection, run by Daewoong Pharmaceutical Co. LTD. at 1 site 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Termination of study due to sponsor's internal decision). 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?
Percentage of subjects with COVID-19 (time frame: Up to 14 days). 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 7 Dec 2022.