COVID-19 PatientsPhase 1NCT04541485
To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
A Phase 1 study testing DWRX2003 in people with COVID-19 Patients, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Patients
- What is being tested?
- DWRX2003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Dec 2020to 23 Mar 2021
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years of age, inclusive at time of signing the ICF.
- Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment.
Who cannot join
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
- Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
- Conditions
- COVID-19 Patients
- Being tested
- DWRX2003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWRX2003Drug
Intramuscularly injection at pre-defined injection sites
PlaceboDrug
Intramuscularly injection at pre-defined injection sites
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1 (96 mg) | Experimental | 24 mg/0.1 mL x 4 sites Receives: Drug: DWRX2003; Drug: Placebo |
| Experimental: Cohort 2 (288 mg) | Experimental | 72 mg/0.3 mL x 4 sites Receives: Drug: DWRX2003; Drug: Placebo |
| Experimental: Cohort 3 (480 mg) | Experimental | 120 mg/0.5 mL x 4 sites Receives: Drug: DWRX2003; Drug: Placebo |
| Experimental: Cohort 4 (672 mg) | Experimental | 168 mg/0.7 mL x 4 sites Receives: Drug: DWRX2003; Drug: Placebo |
| Experimental: Cohort 5 (960 mg) | Experimental | 240 mg/1.0 mL x 4 sites Receives: Drug: DWRX2003; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Measured: follow-up 42 days after dosing
Secondary outcomes (2)
Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen
Measured: follow-up 42 days after dosing
Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen
Measured: at Day 3, 7, 10 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start4 Dec 2020
- Primary completion3 Mar 2021
- Study completion23 Mar 2021
Why it stopped: Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PatientsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 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
- NCT04541485
- Sponsor's protocol ID
- DW_DWJ1516101_Phillipphines
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04541485
- Acronym / sponsor ID
- DW_DWJ1516101_Phillipphines
- Conditions
- COVID-19 Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 9 Sep 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.
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1 (96 mg) | Experimental | Drug: DWRX2003, Drug: Placebo24 mg/0.1 mL x 4 sites |
| Experimental: Cohort 2 (288 mg) | Experimental | Drug: DWRX2003, Drug: Placebo72 mg/0.3 mL x 4 sites |
| Experimental: Cohort 3 (480 mg) | Experimental | Drug: DWRX2003, Drug: Placebo120 mg/0.5 mL x 4 sites |
| Experimental: Cohort 4 (672 mg) | Experimental | Drug: DWRX2003, Drug: Placebo168 mg/0.7 mL x 4 sites |
| Experimental: Cohort 5 (960 mg) | Experimental | Drug: DWRX2003, Drug: Placebo240 mg/1.0 mL x 4 sites |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18 and 65 years of age, inclusive at time of signing the ICF.
- Subjects with low to moderate risk defined as NEWS COVID-19 infection as confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay 72 hours prior to clinical trial enrollment.
Key exclusion criteria (2 listed)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note patients with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
- Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study
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 |
|---|---|---|
| DWRX2003Intramuscularly injection at pre-defined injection sites | Drug | Experimental: Cohort 1 (96 mg), Experimental: Cohort 2 (288 mg), Experimental: Cohort 3 (480 mg), Experimental: Cohort 4 (672 mg), Experimental: Cohort 5 (960 mg) |
| PlaceboIntramuscularly injection at pre-defined injection sites | Drug | Experimental: Cohort 1 (96 mg), Experimental: Cohort 2 (288 mg), Experimental: Cohort 3 (480 mg), Experimental: Cohort 4 (672 mg), Experimental: Cohort 5 (960 mg) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: follow-up 42 days after dosing
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
2 secondary outcomes
Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen
Time frame: follow-up 42 days after dosing
Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen
Time frame: at Day 3, 7, 10 and 14
Results and safety
The study was stopped early (reason given: Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
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 1 study testing DWRX2003 in people with COVID-19 Patients, 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 2 inclusion and 2 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 23 Sep 2021. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.). 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?
Incidence of Treatment-Emergent Adverse Events (time frame: follow-up 42 days after dosing). 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 23 Sep 2021.