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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04748757 |
|
Full text link
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 11, 2023, 8 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : March 11, 2023, 8 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-02-10 |
|
Recruitment status
Last imported at : March 11, 2023, 8 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age ≥ 19 years positive test for sars-cov-2 virus (anytime during current illness episode) admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation) |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
known allergy to any of the ingredients or components of the investigational product known pregnancy moribund and not expected to survive beyond 24 hours known or suspected risk for serious bleeding complications (note that disseminated intravascular coagulopathy (dic) is an expected finding in patient with sepsis and covid-19 disease and is not an exclusion criterion on its own) acute or chronic renal failure (dialysis dependent) |
|
Number of arms
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
|
Funding
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Lawson Health Research Institute |
|
Inclusion age min
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
19 |
|
Inclusion age max
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Canada |
|
Type of patients
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Critical disease at enrollment |
|
Severity scale
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
8: Critical disease at enrollment |
|
Total sample size
Last imported at : March 11, 2023, 8 p.m. Source : ClinicalTrials.gov |
18 |
|
primary outcome
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Data completeness;Enrollment;Protocol adherence |
|
Notes
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Feb. 12, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "50 microg/kg", "treatment_id": 1078, "treatment_name": "Recombinant human annexin a5", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "100 microg/kg", "treatment_id": 1078, "treatment_name": "Recombinant human annexin a5", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |