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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.

Brief Summary:
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.

Condition or disease Intervention/treatment Phase
COVID-19 Patients Drug: DWRX2003 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 4, 2020
Actual Primary Completion Date : March 3, 2021
Actual Study Completion Date : March 23, 2021

Arm Intervention/treatment
Experimental: Experimental: Cohort 1 (96 mg)
24 mg/0.1 mL x 4 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites

Experimental: Experimental: Cohort 2 (288 mg)
72 mg/0.3 mL x 4 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites

Experimental: Experimental: Cohort 3 (480 mg)
120 mg/0.5 mL x 4 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites

Experimental: Experimental: Cohort 4 (672 mg)
168 mg/0.7 mL x 4 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites

Experimental: Experimental: Cohort 5 (960 mg)
240 mg/1.0 mL x 4 sites
Drug: DWRX2003
Intramuscularly injection at pre-defined injection sites

Drug: Placebo
Intramuscularly injection at pre-defined injection sites




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen [ Time Frame: follow-up 42 days after dosing ]
  2. Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen [ Time Frame: at Day 3, 7, 10 and 14 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541485


Locations
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Korea, Republic of
Deawoong pharmaceutical
Seoul, Gangnam-gu, Korea, Republic of, 06170
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04541485    
Other Study ID Numbers: DW_DWJ1516101_Phillipphines
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases