COVID-19 Patients
Conditions
Brief summary
This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
Interventions
DRUGDWRX2003
Intramuscularly injection at pre-defined injection sites
DRUGPlacebo
Intramuscularly injection at pre-defined injection sites
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed