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

Daewoong Pharmaceutical

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: DWRX2003

Study type: Interventional

Funder types: Industry

Identifiers

NCT05226533

DW_DWJ1516202

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 3 patient groups, including a placebo group

Niclosamide 432mg

Experimental group

Description:

Niclosamide 432mg (intramuscular injection) + Remdesivir

Treatment:

Drug: DWRX2003

Niclosamide 960mg

Experimental group

Description:

Niclosamide 960mg (intramuscular injection) + Remdesivir

Treatment:

Drug: DWRX2003

Placebo

Placebo Comparator group

Description:

Placebo (intramuscular injection) + Remdesivir

Treatment:

Drug: Placebo