| Trial registration number
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NCT04633772 |
Full text link
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04633772
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First author
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
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Robson AS Santos
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Contact
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
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santos@icb.ufmg.br
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Registration date
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-11-18
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Recruitment status
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- admission to the intensive care unit with severe pneumonia criteria (clinical signs of
pneumonia + one of the following criteria: respiratory rate greater than 30/minute;
signs of respiratory effort, sato2 < 90% in room air);
- covid-19 confirmed or highly suspicious (positive contact or suggestive image)
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Exclusion criteria
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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- diagnosed with cancer (at any stage);
- hemodynamic instability (need for vasopressors);
- pregnant women; immunocompromised patients;
- palliative care;
- inclusion in any other interventionist study;
- heart failure as a predominant cause of acute respiratory failure;
- decompensated liver cirrhosis;
- hiv +;
- dialysis;
- home / long-term oxygen therapy;
- idiopathic pulmonary fibrosis
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Number of arms
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Erasme University Hospital
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Inclusion age min
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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17
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Inclusion age max
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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81
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Countries
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Brazil
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Type of patients
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Nov. 11, 2021, 4:30 p.m.
Source : ClinicalTrials.gov
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112
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primary outcome
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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supplemental oxygen-free days (SOFDs)
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Notes
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 1/Phase 2
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Arms
Last imported at : Nov. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 85, "treatment_name": "Angiotensin 1-7", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]
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