Severe COVID-19Phase 3NCT04713176
Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
A Phase 3 study testing DWJ1248 with Remdesivir in people with Severe COVID-19, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Severe COVID-19
- What is being tested?
- DWJ1248 with Remdesivir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Feb 2021to 9 Dec 2022
- 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
- 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 COVID-19 according to RT-PCR test(within 10 days)
- Subjects who need to be hospitalized and injected Remdesivir
Who cannot join
- Subjects who cannot orally administer the investigational products
- Subjects who requiring mechanical ventilation or ECMO
- Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
- Subjects who need administration of immunosuppressants
- Subjects who are allergic or sensitive to investigational products or its ingredients
- Crcl < 30 mL/min or eGFR < 30 mL/min/1.73m^2
- AST or ALT >= 5xULN
- 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 III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
- Conditions
- Severe COVID-19
- Being tested
- DWJ1248 with Remdesivir, Placebo with Remdesivir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1248 with RemdesivirDrug
1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Placebo with RemdesivirDrug
1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
| Study group | Role | What they receive |
|---|---|---|
| DWJ1248 with Remdesivir | Experimental | Camostat mesylate 200 mg, Remdesivir Receives: Drug: DWJ1248 with Remdesivir |
| Placebo with Remdesivir | Placebo comparator | Placebo, Remdesivir Receives: Drug: Placebo with Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days
Percentage of patients with death(ordinal scale of 8) or ECMO patients(ordinal scale of 7)
Measured: Up to 29 days
Secondary outcomes (4)
Time to recovery
Measured: Day 3,5,8,11,15,22,29
Desirable of Outcome Ranking (DOOR)
The DOOR is scored by evaluating two items: ordinal scale and serious adverse events.
DOORs are as follows: 1: Recovery (corresponding to the ordinal scale of 1, 2, or 3); 2: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with no serious adverse events; 3: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with serious adverse events; 4: No change (no change in the ordinal scale compared to baseline) with no serious adverse events; 5: No change (no change in the ordinal scale compared to baseline) with serious adverse event regardless of causality; 6: Deterioration (increased by more than 1 score of the ordinal scale compared to baseline); 7: Death
Measured: Day 15,29
Duration of Hospitalization
The duration of hospitalization (days)
Measured: Day 29
Time to death
The percent of participants
Measured: Day 15,29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start2 Feb 2021
- Primary completion2 May 2022
- Study completion9 Dec 2022
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 Severe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 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
- NCT04713176
- Sponsor's protocol ID
- DW_DWJ1248302
- Status last verified
- Sep 2023
- First submitted
- 14 Jan 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04713176
- Acronym / sponsor ID
- DW_DWJ1248302
- Conditions
- Severe COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of study due to sponsor's internal decision
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 19 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.
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ1248 with Remdesivir | Experimental | Drug: DWJ1248 with RemdesivirCamostat mesylate 200 mg, Remdesivir |
| Placebo with Remdesivir | Placebo comparator | Drug: Placebo with RemdesivirPlacebo, Remdesivir |
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 COVID-19 according to RT-PCR test(within 10 days)
- Subjects who need to be hospitalized and injected Remdesivir
Key exclusion criteria (8 listed)
- Subjects who cannot orally administer the investigational products
- Subjects who requiring mechanical ventilation or ECMO
- Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
- Subjects who need administration of immunosuppressants
- Subjects who are allergic or sensitive to investigational products or its ingredients
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 |
|---|---|---|
| DWJ1248 with Remdesivir1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV | Drug | DWJ1248 with Remdesivir |
| Placebo with Remdesivir1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV | Drug | Placebo with Remdesivir |
Primary outcome
Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days
Time frame: Up to 29 days
Percentage of patients with death(ordinal scale of 8) or ECMO patients(ordinal scale of 7)
4 secondary outcomes
Time to recovery
Time frame: Day 3,5,8,11,15,22,29
Desirable of Outcome Ranking (DOOR)
Time frame: Day 15,29
Duration of Hospitalization
Time frame: Day 29
Time to death
Time frame: Day 15,29
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 29 Sep 2023.
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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 with Remdesivir in people with Severe 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 8 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 29 Sep 2023. 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?
Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days (time frame: Up to 29 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 29 Sep 2023.