Study Stopped
Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.
To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients
1 other identifier
interventional
2
1 country
1
Brief Summary
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedStudy Start
First participant enrolled
December 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2021
CompletedSeptember 23, 2021
September 1, 2021
3 months
September 7, 2020
September 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
follow-up 42 days after dosing
Secondary Outcomes (2)
Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen
follow-up 42 days after dosing
Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen
at Day 3, 7, 10 and 14
Study Arms (5)
Experimental: Cohort 1 (96 mg)
EXPERIMENTAL24 mg/0.1 mL x 4 sites
Experimental: Cohort 2 (288 mg)
EXPERIMENTAL72 mg/0.3 mL x 4 sites
Experimental: Cohort 3 (480 mg)
EXPERIMENTAL120 mg/0.5 mL x 4 sites
Experimental: Cohort 4 (672 mg)
EXPERIMENTAL168 mg/0.7 mL x 4 sites
Experimental: Cohort 5 (960 mg)
EXPERIMENTAL240 mg/1.0 mL x 4 sites
Interventions
Intramuscularly injection at pre-defined injection sites
Intramuscularly injection at pre-defined injection sites
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deawoong pharmaceutical
Seoul, Gangnam-gu, 06170, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2020
First Posted
September 9, 2020
Study Start
December 4, 2020
Primary Completion
March 3, 2021
Study Completion
March 23, 2021
Last Updated
September 23, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share