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

Phase 1

Terminated

• Conditions: COVID-19 Patients
• Interventions: Drug: DWRX2003; Drug: Placebo

• Registration Number: NCT04541485
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-09
• Study Start: 2020-12-04
• Primary Completion: 2021-03-03
• Study Completion: 2021-03-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Cohort 2 (288 mg)	DWRX2003	72 mg/0.3 mL x 4 sites
Experimental: Cohort 3 (480 mg)	DWRX2003	120 mg/0.5 mL x 4 sites
Experimental: Cohort 1 (96 mg)	DWRX2003	24 mg/0.1 mL x 4 sites
Experimental: Cohort 1 (96 mg)	Placebo	24 mg/0.1 mL x 4 sites
Experimental: Cohort 2 (288 mg)	Placebo	72 mg/0.3 mL x 4 sites
Experimental: Cohort 3 (480 mg)	Placebo	120 mg/0.5 mL x 4 sites
Experimental: Cohort 4 (672 mg)	DWRX2003	168 mg/0.7 mL x 4 sites
Experimental: Cohort 4 (672 mg)	Placebo	168 mg/0.7 mL x 4 sites
Experimental: Cohort 5 (960 mg)	DWRX2003	240 mg/1.0 mL x 4 sites
Experimental: Cohort 5 (960 mg)	Placebo	240 mg/1.0 mL x 4 sites

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	follow-up 42 days after dosing	Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Deawoong pharmaceutical; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of