| Trial registration number
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NCT04381858 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04381858
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First author
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Jose Manuel Arreola
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Contact
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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dr.jmag@gmail.com
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-05-11
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Recruitment status
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.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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single-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
patients who are admitted to hospital centers with a positive rt-qpcr sars-cov-2 test or a ct scan compatible with a diagnosis of covid-19 pneumonia, in addition to one of the following two criteria:
severe respiratory failure [respiratory rate> 25 - <35 x minute, oxygen saturation ≤ 90% with reservoir mask (fio2 = 100%)]
requiring invasive mechanical ventilation.
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- patients with a viral infection other than covid-19
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Centenario Hospital Miguel Hidalgo
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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16
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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90
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Mexico
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Severe disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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6: Severe disease at enrollment
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Total sample size
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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196
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Mean time with invasive mechanical ventilation;Rate and time to dead;Mean hospitalization time;Rate of severe ARDS;Mean Oxigenation index evolution
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.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 3
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 597, "treatment_name": "Human immunoglobulin", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}]
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