Back to resultsTo Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
Primary Purpose
COVID-19 Patients
Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWRX2003
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Patients
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Deawoong pharmaceutical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
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)
Arm Description
24 mg/0.1 mL x 4 sites
72 mg/0.3 mL x 4 sites
120 mg/0.5 mL x 4 sites
168 mg/0.7 mL x 4 sites
240 mg/1.0 mL x 4 sites
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcome Measures
Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen
Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen
Full Information
NCT ID
NCT04541485
First Posted
September 7, 2020
Last Updated
September 16, 2021
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04541485
Brief Title
To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
March 3, 2021 (Actual)
Study Completion Date
March 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Cohort 1 (96 mg)
Arm Type
Experimental
Arm Description
24 mg/0.1 mL x 4 sites
Arm Title
Experimental: Cohort 2 (288 mg)
Arm Type
Experimental
Arm Description
72 mg/0.3 mL x 4 sites
Arm Title
Experimental: Cohort 3 (480 mg)
Arm Type
Experimental
Arm Description
120 mg/0.5 mL x 4 sites
Arm Title
Experimental: Cohort 4 (672 mg)
Arm Type
Experimental
Arm Description
168 mg/0.7 mL x 4 sites
Arm Title
Experimental: Cohort 5 (960 mg)
Arm Type
Experimental
Arm Description
240 mg/1.0 mL x 4 sites
Intervention Type
Drug
Intervention Name(s)
DWRX2003
Intervention Description
Intramuscularly injection at pre-defined injection sites
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscularly injection at pre-defined injection sites
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
follow-up 42 days after dosing
Secondary Outcome Measure Information:
Title
Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen
Time Frame
follow-up 42 days after dosing
Title
Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen
Time Frame
at Day 3, 7, 10 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Deawoong pharmaceutical
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06170
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
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