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To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541485
Recruitment Status : Terminated (Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.)
First Posted : September 9, 2020
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Tracking Information
First Submitted Date  ICMJE September 7, 2020
First Posted Date  ICMJE September 9, 2020
Last Update Posted Date September 23, 2021
Actual Study Start Date  ICMJE December 4, 2020
Actual Primary Completion Date March 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
Official Title  ICMJE Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients
Brief Summary This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Patients
Intervention  ICMJE
  • Drug: DWRX2003
    Intramuscularly injection at pre-defined injection sites
  • Drug: Placebo
    Intramuscularly injection at pre-defined injection sites
Study Arms  ICMJE
  • Experimental: Experimental: Cohort 1 (96 mg)
    24 mg/0.1 mL x 4 sites
    Interventions:
    • Drug: DWRX2003
    • Drug: Placebo
  • Experimental: Experimental: Cohort 2 (288 mg)
    72 mg/0.3 mL x 4 sites
    Interventions:
    • Drug: DWRX2003
    • Drug: Placebo
  • Experimental: Experimental: Cohort 3 (480 mg)
    120 mg/0.5 mL x 4 sites
    Interventions:
    • Drug: DWRX2003
    • Drug: Placebo
  • Experimental: Experimental: Cohort 4 (672 mg)
    168 mg/0.7 mL x 4 sites
    Interventions:
    • Drug: DWRX2003
    • Drug: Placebo
  • Experimental: Experimental: Cohort 5 (960 mg)
    240 mg/1.0 mL x 4 sites
    Interventions:
    • Drug: DWRX2003
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 16, 2021)
2
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2020)
40
Actual Study Completion Date  ICMJE March 23, 2021
Actual Primary Completion Date March 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Between 18 and 65 years of age, inclusive at time of signing the ICF.
  2. 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:

  1. 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).
  2. Significant history, clinical manifestation of any medical disorder or any comorbid conditions which in the opinion of the investigator may interfere with the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04541485
Other Study ID Numbers  ICMJE DW_DWJ1516101_Phillipphines
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daewoong Pharmaceutical Co. LTD.
Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP