Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
NCT ID: NCT05226533
Last Updated: 2023-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2022-03-31
2022-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Niclosamide 432mg
Niclosamide 432mg (intramuscular injection) + Remdesivir
DWRX2003
Intramuscular injection of DWRX2003
Niclosamide 960mg
Niclosamide 960mg (intramuscular injection) + Remdesivir
DWRX2003
Intramuscular injection of DWRX2003
Placebo
Placebo (intramuscular injection) + Remdesivir
Placebo
Intramuscular injection of placebo
Interventions
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DWRX2003
Intramuscular injection of DWRX2003
Placebo
Intramuscular injection of placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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RSUP Fatmawati
Jakarta, DKI Jakarta, Indonesia
RSUPN Cipto Mangunkusumo
Jakarta, DKI Jakarta, Indonesia
RS. Hasan Sadikin
Bandung, West Java, Indonesia
Countries
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Other Identifiers
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DW_DWJ1516202
Identifier Type: -
Identifier Source: org_study_id
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