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

Phase 2

Terminated

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

• Registration Number: NCT05226533
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-07
• Study Start: 2022-03-31
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niclosamide 432mg	DWRX2003	Niclosamide 432mg (intramuscular injection) + Remdesivir
Placebo	Placebo	Placebo (intramuscular injection) + Remdesivir
Niclosamide 960mg	DWRX2003	Niclosamide 960mg (intramuscular injection) + Remdesivir

Primary Outcome Measures

Name	Time	Method
The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14.	day 14	mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) until day 14.

Trial Locations

Locations (3)

RSUPN Cipto Mangunkusumo; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

RS. Hasan Sadikin; 🇮🇩 Bandung, Jawa Barat, Indonesia

RSUP Fatmawati; 🇮🇩 Jakarta, DKI Jakarta, Indonesia