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| Column | Value |
|---|---|
| Trial registration number | NCT04609462 |
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Full text link
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Feb. 11, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
gusospin@gmail.com |
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Registration date
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-10-30 |
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Recruitment status
Last imported at : Feb. 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - adults > 18 years. - emergency or icu admission with suspected/confirmed sars-cov-2 infection. - moderate/severe acute respiratory failure: - pao2/fio2 < 200. - use of accessory muscles. - breathing rate > 25 x minute. - have a progression < 6 hours since meeting the definition of moderate/severe acute respiratory failure secondary to suspected/confirmed sars-cov-2 infection. |
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Exclusion criteria
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- adults < 18 years. - indication for immediate orotracheal intubation. - pregnant woman / positive pregnancy test at the time of potential inclusion in the study. - chronic liver disease / liver cirrhosis child-pugh c. - confirmation of active bacterial or fungal infection. - uncontrolled hiv/aids disease (defined by presence of viral load > 200 copies/ml). - previous history of copd gold c - d. - history of copd requiring hospitalization - hospitalization / icu in the last year. - known history of congestive heart failure nyha iii - iv. - left ventricular ejection fraction < 45% previously known. - highly suspected or confirmed cardiogenic pulmonary edema. - hypercapnic respiratory failure (paco2 > 55 mmhg). - central/peripheral demyelinating disorders due to medical history or high suspicion of these at the time of study eligibility. - patient who in the investigator's judgment suggests a progression to death is imminent and inevitable within the next 24 hours. - any serious medical condition or clinical laboratory test abnormality that, in the investigator's judgment, prevents safe patient participation and completion of the study. - participation in another clinical trial (except one related to sars-cov-2 - criteria to be discussed between group of researches). |
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Number of arms
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Fundacion Clinica Valle del Lili |
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Inclusion age min
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Colombia |
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Type of patients
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : Feb. 20, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
199 |
|
primary outcome
Last imported at : April 6, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Clinical recovery;Intubation rate |
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Notes
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : Oct. 31, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 575, "treatment_name": "High flow nasal cannula", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |