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| Column | Value |
|---|---|
| Trial registration number | NCT04978051 |
|
Full text link
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
|
|
First author
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
2021-07-27 |
|
Recruitment status
Last imported at : Aug. 4, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: adult patients (18 years or older), both sexes sars-cov-2 infection confirmed by pcr less than 4 days before randomization hospitalized with a diagnosis of sars-cov-2 pneumonia radiographic evidence of pulmonary infiltrates grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition po2/fio2 <380 men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception obtaining the informed consent of the patient or the legal representative. |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
imminent death (life expectancy less than 72h) known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation invasive mechanical ventilation participation in any other clinical trial alt or ast > 5 x uln creatinine clearance <50 ml/min using the cockcroft-gault formula for participants '18 years old [cockcroft 1976] patients with recent acute coronary syndrome (<1 month) patients with a history of stroke positive pregnancy test pregnant or lactating woman |
|
Number of arms
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Sebastian Videla |
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Inclusion age min
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Spain |
|
Type of patients
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
|
Severity scale
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
|
Total sample size
Last imported at : Aug. 4, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
73 |
|
primary outcome
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Efficacy of experimental treatment;Safety of experimental treatment |
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Notes
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : July 28, 2021, noon Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 621, "treatment_name": "Icatibant", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |