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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05226533
• Other study ID #: DW_DWJ1516202
• Status: Terminated
• Phase: Phase 2
• Start date: March 31, 2022
• Est. completion date: December 21, 2022

Study information

• Verified date: February 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 21, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• DWRX2003
Intramuscular injection of DWRX2003
• Placebo
Intramuscular injection of placebo

Locations

Country	Name	City	State
Indonesia	RS. Hasan Sadikin	Bandung	Jawa Barat
Indonesia	RSUP Fatmawati	Jakarta	DKI Jakarta
Indonesia	RSUPN Cipto Mangunkusumo	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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