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

September 16, 2021 updated by: Daewoong Pharmaceutical Co. LTD.

Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06170
        • Deawoong pharmaceutical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
follow-up 42 days after dosing

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 4, 2020

Primary Completion (ACTUAL)

March 3, 2021

Study Completion (ACTUAL)

March 23, 2021

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 7, 2020

First Posted (ACTUAL)

September 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWJ1516101_Phillipphines

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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