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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05226533

Enrollment

Registered

2022-02-07

Start date

2022-03-31

Completion date

2022-12-21

Last updated

2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

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

Interventions

DRUGDWRX2003

Intramuscular injection of DWRX2003

DRUGPlacebo

Intramuscular injection of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026