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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05226533 |
|
Full text link
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
2022-02-07 |
|
Recruitment status
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
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
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
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. |
|
Number of arms
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Daewoong Pharmaceutical Co. LTD. |
|
Inclusion age min
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
Indonesia |
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Type of patients
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
|
Total sample size
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
1 |
|
primary outcome
Last imported at : Feb. 3, 2023, 8 p.m. Source : ClinicalTrials.gov |
The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14. |
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Notes
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Feb. 8, 2022, 2:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "432mg;IM", "treatment_id": 427, "treatment_name": "Dwrx2003", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "960mg;IM", "treatment_id": 427, "treatment_name": "Dwrx2003", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |