| Trial registration number
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NCT04626089 |
Full text link
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04626089
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First author
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Fausto González-Villagrán, MD
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Contact
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Jorge Gonzalez-Canudas, jogonzalez@silanes.com.mx (PI email not reported)
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Registration date
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-11-12
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Recruitment status
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Withdrawn
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Study design
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 13, 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 : Nov. 13, 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:
≥ 18 years old
ability to understand and the willingness to sign a written informed consent document before any study procedure
metabolic syndrome or type 2 diabetes
coronavirus infection, severe acute respiratory syndrome sars-cov- 2 confirmed by the polymerase chain reaction test (pcr) ≤ 4 days before of the randomization.
hospitalized patient.
radiographic evidence of pulmonary infiltrates
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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participation in any other clinical trial of an experimental treatment for covid-19
evidence of multi-organ failure
require mechanical ventilation before randomization
pregnant patients
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Number of arms
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Laboratorios Silanes S.A. de C.V.
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Inclusion age min
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Mexico
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Type of patients
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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0
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primary outcome
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Viral Load
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Notes
Last imported at : Nov. 13, 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 2
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Arms
Last imported at : Nov. 13, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 795, "treatment_name": "Metformin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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