COVID-19Phase 2NCT05226533
Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
A Phase 2 study testing DWRX2003 in people with COVID-19, run by Daewoong Pharmaceutical Co. LTD. at 3 sites in Indonesia.
Trial summary
Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- 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
- 1 participants
- Where
- 3 sitesIndonesia
- Study dates
- 31 Mar 2022to 21 Dec 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at time of signing the Informed Consent Form (ICF).
- SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization.
- Hospitalized patients who meet the criteria of moderate or severe COVID-19.
- Patients who are not pregnant, based on urine pregnancy test during screening, and randomization.
- Female patients of childbearing potential practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment.
- Male patient and/or Female patient's partner agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment.
- Patients who are anticipated to available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
- Patients who agree to give written informed consent and are willing to participate in the study.
Who cannot join
- Patients with BMI ≥30 and/or body weight < 40kg
- Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit.
- Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area.
- Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.)
- Patients who have active malignancy, history of active malignancy or chemotherapy within 1 year from the screening.
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
RS. Hasan Sadikin
Bandung, West Java
RSUP Fatmawati
Jakarta, DKI Jakarta
RSUPN Cipto Mangunkusumo
Jakarta, DKI Jakarta
About this study
Official title: A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients
Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.
- Conditions
- COVID-19
- Being tested
- DWRX2003, 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.
DWRX2003Drug
Intramuscular injection of DWRX2003
PlaceboDrug
Intramuscular injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| Niclosamide 432mg | Experimental | Niclosamide 432mg (intramuscular injection) + Remdesivir Receives: Drug: DWRX2003 |
| Niclosamide 960mg | Experimental | Niclosamide 960mg (intramuscular injection) + Remdesivir Receives: Drug: DWRX2003 |
| Placebo | Placebo comparator | Placebo (intramuscular injection) + Remdesivir Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14.
mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) until day 14.
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start31 Mar 2022
- Primary completion16 Dec 2022
- Study completion21 Dec 2022
Why it stopped: Study stopped due to difficulties in patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 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
- NCT05226533
- Sponsor's protocol ID
- DW_DWJ1516202
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2022
- Last updated
- 10 Feb 2023
- 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 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05226533
- Acronym / sponsor ID
- DW_DWJ1516202
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to difficulties in patient recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 7 Feb 2022 (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.
Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Niclosamide 432mg | Experimental | Drug: DWRX2003Niclosamide 432mg (intramuscular injection) + Remdesivir |
| Niclosamide 960mg | Experimental | Drug: DWRX2003Niclosamide 960mg (intramuscular injection) + Remdesivir |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (intramuscular injection) + Remdesivir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years at time of signing the Informed Consent Form (ICF).
- SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization.
- Hospitalized patients who meet the criteria of moderate or severe COVID-19.
- Patients who are not pregnant, based on urine pregnancy test during screening, and randomization.
- Female patients of childbearing potential practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment.
Key exclusion criteria (5 listed)
- Patients with BMI ≥30 and/or body weight < 40kg
- Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit.
- Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area.
- Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.)
- Patients who have active malignancy, history of active malignancy or chemotherapy within 1 year from the screening.
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 |
|---|---|---|
| DWRX2003Intramuscular injection of DWRX2003 | Drug | Niclosamide 432mg, Niclosamide 960mg |
| PlaceboIntramuscular injection of placebo | Drug | Placebo |
Primary outcome
The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14.
Time frame: day 14
mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) until day 14.
Results and safety
The study was stopped early (reason given: Study stopped due to difficulties in patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DWRX2003 in people with COVID-19, run by Daewoong Pharmaceutical Co. LTD. at 3 sites in Indonesia.
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 8 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Study stopped due to difficulties in patient recruitment). 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?
The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14. (time frame: day 14). 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 10 Feb 2023.