Mild to Moderate COVID-19Phase 2/3NCT04521296
Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo
A Phase 2/3 study testing Part 1 and Part 2 in people with Mild to Moderate COVID-19, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mild to Moderate COVID-19
- What is being tested?
- Part 1 and Part 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Sep 2020to 18 Mar 2022
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 19 as of the signed date in written consent
- Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS is 0-6 or if one item is 3 points)
- Subjects who have symptoms within 7 days or 72 hours after diagnosis
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 52 weeks 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 Double-blind, Randomized, Placebo-controlled, Multi-center, Phase II/III Study to Evaluate the Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19
To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.
- Conditions
- Mild to Moderate COVID-19
- Being tested
- Part 1, Part 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1Other
- DWJ1248 600mg PO (100mg 2 tab, TID)
Part 2Other
- DWJ1248 600mg PO (200mg 1 tab, TID)
| Study group | Role | What they receive |
|---|---|---|
| DWJ1248 | Experimental | Camostat mesylate Receives: Other: Part 1; Other: Part 2 |
| Placebo | Placebo comparator | Placebo Receives: Other: Part 1; Other: Part 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part 1) Time to SARS-CoV-2 eradication
Time to reach undetectable SARS-CoV-2 RNA level
Measured: Up to 28 days
(Part 2) Time to clinical improvement of subjective symptoms
Clinical improvement of subjective symptoms (days)
Measured: Up to 14 days
Secondary outcomes (3)
(Part 1) Rate of SARS-CoV-2 eradication
Percent of patients with undetectable SARS-CoV-2 RNA level
Measured: Days 4, 7, 10, and 14
(Part 1/2) Time to clinical improvement of subjective symptoms
Measured: Up to 28 days
(Part 2) Change from baseline of subjective symptom scores
Measured: Days 4, 7, 10, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start11 Sep 2020
- Primary completion14 Sep 2021
- Study completion18 Mar 2022
Why it stopped: Changes in drug development plans
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate COVID-19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 432 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
- NCT04521296
- Sponsor's protocol ID
- DW_DWJ1248201
- Status last verified
- Oct 2021
- First submitted
- 7 Jul 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim YS, Jeon SH, Kim J, Koh JH, Ra SW, Kim JW, Kim Y, Kim CK, Shin YC, Kang BD, Kang SJ, Park CH, Lee B, Lee JY, Lee CH, Choi JP, Kim JY, Yu SN, Peck KR, Kim SH, Heo JY, Kim HA, Park HJ, Choi J, Han J, Kim J, Kim HJ, Han SH, Yoon A, Park M, Park S, Kim Y, Jung M, Oh MD. A Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study To Evaluate the Efficacy and Safety of Camostat Mesylate (DWJ1248) in Adult Patients with Mild to Moderate COVID-19. Antimicrob Agents Chemother. 2023 Jan 24;67(1):e0045222. doi: 10.1128/aac.00452-22. Epub 2022 Dec 14.
PubMed 36515544
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase II/III Study to Evaluate the Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04521296
- Acronym / sponsor ID
- DW_DWJ1248201
- Conditions
- Mild to Moderate COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in drug development plans
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 20 Aug 2020 (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 efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ1248 | Experimental | Other: Part 1, Other: Part 2Camostat mesylate |
| Placebo | Placebo comparator | Other: Part 1, Other: Part 2Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over the age of 19 as of the signed date in written consent
- Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS is 0-6 or if one item is 3 points)
- Subjects who have symptoms within 7 days or 72 hours after diagnosis
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 52 weeks 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 |
|---|---|---|
| Part 1- DWJ1248 600mg PO (100mg 2 tab, TID) | Other | DWJ1248, Placebo |
| Part 2- DWJ1248 600mg PO (200mg 1 tab, TID) | Other | DWJ1248, Placebo |
Primary outcome
(Part 1) Time to SARS-CoV-2 eradication
Time frame: Up to 28 days
Time to reach undetectable SARS-CoV-2 RNA level
(Part 2) Time to clinical improvement of subjective symptoms
Time frame: Up to 14 days
Clinical improvement of subjective symptoms (days)
3 secondary outcomes
(Part 1) Rate of SARS-CoV-2 eradication
Time frame: Days 4, 7, 10, and 14
(Part 1/2) Time to clinical improvement of subjective symptoms
Time frame: Up to 28 days
(Part 2) Change from baseline of subjective symptom scores
Time frame: Days 4, 7, 10, 14, 21 and 28
Results and safety
The study was stopped early (reason given: Changes in drug development plans). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 36515544Kim YS, Jeon SH, Kim J, Koh JH, Ra SW, Kim JW, Kim Y, Kim CK, Shin YC, Kang BD, Kang SJ, Park CH, Lee B, Lee JY, Lee CH, Choi JP, Kim JY, Yu SN, Peck KR, Kim SH, Heo JY, Kim HA, Park HJ, Choi J, Han J, Kim J, Kim HJ, Han SH, Yoon A, Park M, Park S, Kim Y, Jung M, Oh MD. A Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study To Evaluate the Efficacy and Safety of Camostat Mesylate (DWJ1248) in Adult Patients with Mild to Moderate COVID-19. Antimicrob Agents Chemother. 2023 Jan 24;67(1):e0045222. doi: 10.1128/aac.00452-22. Epub 2022 Dec 14.
- 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 2/3 study testing Part 1 and Part 2 in people with Mild to Moderate COVID-19, 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 3 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 15 Jun 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Changes in drug development plans). 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?
(Part 1) Time to SARS-CoV-2 eradication (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521296, which also lists 1 linked publication.
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 15 Jun 2022.