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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04348383 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-16 |
|
Recruitment status
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : Feb. 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: acceptance of participation in the study by the patient or legal representative. patients of any gender, 18 years or older. confirmed diagnosis by pcr+ of sars-cov-2 infection. covid-19 positive patients who grades 4, 5 or 6. grade 4: hospitalized requiring oxygen therapy. grade 5: hospitalized requiring high-flow oxygen therapy, noninvasive mechanical ventilation, or both. levels of il-6 ≥ 3 times the upper limit of normality |
|
Exclusion criteria
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
acute bleeding. thrombolytic treatment and anticoagulant treatment at therapeutic doses. pregnancy or lactation. patients with active malignant tumour, other serious systemic or neuropsychiatric diseases. patients participating in other clinical trials in the last month. inability to give informed consent or to accomplish the requirements of the diagnostic tests. patients with hypersensitivity to defibrotide. |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Spain |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
156 |
|
primary outcome
Last imported at : Feb. 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Clinical improvement. |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.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 : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 390, "treatment_name": "Defibrotide", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |