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

NCT05226533 | Terminated Phase 2 DMC

• 1 other identifier: DW_DWJ1516202
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Niclosamide 432mg

EXPERIMENTAL

Niclosamide 432mg (intramuscular injection) + Remdesivir

Drug: DWRX2003

Niclosamide 960mg

EXPERIMENTAL

Niclosamide 960mg (intramuscular injection) + Remdesivir

Drug: DWRX2003

Placebo

PLACEBO COMPARATOR

Placebo (intramuscular injection) + Remdesivir

Drug: Placebo

Interventions

DWRX2003 DRUG

Intramuscular injection of DWRX2003

Niclosamide 432mg; Niclosamide 960mg

Placebo DRUG

Intramuscular injection of placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (3)

RSUP Fatmawati

Jakarta, DKI Jakarta, Indonesia

Location

RSUPN Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia

Location

RS. Hasan Sadikin

Bandung, West Java, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 7, 2022
• Study Start: March 31, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 21, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)