Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
DWRX2003
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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.
Exclusion Criteria:
- Patients with BMI ≥30.
- 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.
Sites / Locations
- RSUP Fatmawati
- RSUPN Cipto Mangunkusumo
- RS. Hasan Sadikin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Niclosamide 432mg
Niclosamide 960mg
Placebo
Arm Description
Niclosamide 432mg (intramuscular injection) + Remdesivir
Niclosamide 960mg (intramuscular injection) + Remdesivir
Placebo (intramuscular injection) + Remdesivir
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05226533
First Posted
February 4, 2022
Last Updated
February 8, 2023
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT05226533
Brief Title
Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to difficulties in patient recruitment
Study Start Date
March 31, 2022 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Niclosamide 432mg
Arm Type
Experimental
Arm Description
Niclosamide 432mg (intramuscular injection) + Remdesivir
Arm Title
Niclosamide 960mg
Arm Type
Experimental
Arm Description
Niclosamide 960mg (intramuscular injection) + Remdesivir
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (intramuscular injection) + Remdesivir
Intervention Type
Drug
Intervention Name(s)
DWRX2003
Intervention Description
Intramuscular injection of DWRX2003
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection of placebo
Primary Outcome Measure Information:
Title
The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14.
Description
mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) until day 14.
Time Frame
day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
RSUP Fatmawati
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
RSUPN Cipto Mangunkusumo
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
RS. Hasan Sadikin
City
Bandung
State/Province
Jawa Barat
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
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