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| Column | Value |
|---|---|
| Trial registration number | NCT04730856 |
|
Full text link
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
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Contact
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Angel Pueyo, angel.pueyo@salud.madrid.org (PI email not reported) |
|
Registration date
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-01-29 |
|
Recruitment status
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: patients admitted to hospital with covid-19, pcr and/or antigens test + sars-cov-2 infection or (presence of infiltrate compatible with chest x-ray or tc) patients with, at least, one of the following evolution disease risk criteria: sat 02<94% need for oxygen therapy or pao2/fio2<300mmhg or estimated pao2/fio2 based on spo2/fio2<300 mmhg. dd>1000µg/l pcr >150mg/l il6 >40pg/ml age > 18 years weight 50-100 kg after receiving oral and written information about the study, patient must give informed consent duly signed and dated before performing any activity related to the study. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
patients who need mechanical ventilation (invasive or non-invasive), high flow nasal cannula or admission to icu at the moment of randomization. current diagnosis of acute bronchial asthma attack. history or clinical suspicion of pulmonary fibrosis. current diagnosis or suspicion of pulmonary thromboembolism or deep vein thrombosis. patients who need anticoagulant treatment due to previous venous or arterial thrombotic disease, or due to atrial fibrillation. patients with pneumonectomy or lobectomy. renal failure with glomerular filtration <30 ml/min/1.73m2 patients with contraindication for anticoagulant treatment. congenital bleeding disorders. hypersensitivity to tinzaparin or ufh or some of its excipients. history of heparin-induced thrombocytopenia. active bleeding or situation that predispose to bleeding. moderate or severe anaemia (hb<10 g/dl) low platelet count < 80000/µl patients with life expectancy less than 3 months due to primary disease evaluated by the physician. patients currently intubated or intubated between the screening and the randomization. pregnancy. |
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Number of arms
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Hospital Universitario Infanta Leonor |
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Inclusion age min
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Spain |
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Type of patients
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
311 |
|
primary outcome
Last imported at : Sept. 17, 2022, 2:30 a.m. Source : ClinicalTrials.gov |
Combined variable that includes outcomes 2, 3 and 4 detailed below;Overall survival at 30 days.;Reduction of suspicion of systemic thrombotic symptomatic events;Use of Mechanical ventilation invasive or non invasive including high flow nasal cannula oxigen |
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Notes
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Jan. 30, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "4500 UI/day ", "treatment_id": 1292, "treatment_name": "Tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100 UI/Kg/day ", "treatment_id": 1292, "treatment_name": "Tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "175 UI/Kg/day", "treatment_id": 1292, "treatment_name": "Tinzaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}] |