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

COVID-19 Patients Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04541485
• Other study ID #: DW_DWJ1516101_Phillipphines
• Status: Terminated
• Phase: Phase 1
• Start date: December 4, 2020
• Est. completion date: March 23, 2021

Study information

• Verified date: September 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 23, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Patients

Intervention

Drug:
• DWRX2003
Intramuscularly injection at pre-defined injection sites
• Placebo
Intramuscularly injection at pre-defined injection sites

Locations

Country	Name	City	State
Korea, Republic of	Deawoong pharmaceutical	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen		follow-up 42 days after dosing
Secondary	Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen		at Day 3, 7, 10 and 14