Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.

Study Overview
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Brief Summary
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Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.

Official Title
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A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients

Conditions
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COVID-19

Intervention / Treatment
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* Drug: DWRX2003
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at time of signing the Informed Consent Form (ICF). SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization. Hospitalized patients who meet the criteria of moderate or severe COVID-19. Patients who are not pregnant, based on urine pregnancy test during screening, and randomization. Female patients of childbearing potential practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment. Male patient and/or Female patient's partner agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment. Patients who are anticipated to available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff. Patients who agree to give written informed consent and are willing to participate in the study. Exclusion Criteria: Patients with BMI ≥30 and/or body weight < 40kg Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit. Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area. Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.) Patients who have active malignancy, history of active malignancy or chemotherapy within 1 year from the screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niclosamide 432mg<br>Niclosamide 432mg (intramuscular injection) + Remdesivir | Drug: DWRX2003<br>* Intramuscular injection of DWRX2003<br>|
| Experimental: Niclosamide 960mg<br>Niclosamide 960mg (intramuscular injection) + Remdesivir | Drug: DWRX2003<br>* Intramuscular injection of DWRX2003<br>|
| Placebo Comparator: Placebo<br>Placebo (intramuscular injection) + Remdesivir | Drug: Placebo<br>* Intramuscular injection of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14. | mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) until day 14. | day 14 |