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

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

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

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: DWRX2003; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • RSUP Fatmawati
    • Jakarta, DKI Jakarta, Indonesia
      • RSUPN Cipto Mangunkusumo
  • Jawa Barat
    • Bandung, Jawa Barat, Indonesia
      • RS. Hasan Sadikin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Niclosamide 432mg; Niclosamide 432mg (intramuscular injection) + Remdesivir	Drug: DWRX2003; Intramuscular injection of DWRX2003
EXPERIMENTAL: Niclosamide 960mg; Niclosamide 960mg (intramuscular injection) + Remdesivir	Drug: DWRX2003; Intramuscular injection of DWRX2003
PLACEBO_COMPARATOR: Placebo; Placebo (intramuscular injection) + Remdesivir	Drug: Placebo; Intramuscular injection of placebo

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in WHO clinical progression scale from baseline to day 4, 7, 10, 14, 21 and 28.	day 4, 7, 10, 14, 21 and 28
Change in NEWS2 from baseline to day 4, 7, 10, 14, 21 and 28.	day 4, 7, 10, 14, 21 and 28.

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2022
• Primary Completion (ACTUAL): December 16, 2022
• Study Completion (ACTUAL): December 21, 2022

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (ACTUAL): February 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: DW_DWJ1516202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No