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| Column | Value |
|---|---|
| Trial registration number | NCT04858412 |
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Full text link
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
bellara@ccf.org |
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Registration date
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-04-26 |
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Recruitment status
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind 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 : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: a. cases: patients with ald and covid-19 pneumonia: clinical, imaging, laboratory, and/or histological diagnosis of alcoholic cirrhosis and/or alcoholic hepatitis child pugh score 5-8, serum creatinine <3, model for end stage liver disease score (meld) <25 diagnosis of covid-19 pneumonia as defined by the who criteria: confirmed sars-cov-2 infection by pcr, evidence of bilateral pulmonary infiltrates on chest radiograph (cxr) or computed tomography (ct) and spo2 <93% or on oxygen supplement age of 21 years or older b. controls: patients without alcoholic liver disease (non-ald) and covid-19 pneumonia: diagnosis of covid-19 pneumonia as defined by the who criteria: confirmed sars-cov-2 infection by pcr, evidence of bilateral pulmonary infiltrates on chest radiograph (cxr) or computed tomography (ct) and spo2 <93% or on oxygen supplement age of 21 years or older |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
(both cases and controls) patients requiring active ventilator support anticoagulant/antiplatelet therapy (for those in the biopsy arm, see randomization schema. if clinically feasible, patients will be asked to hold their anticoagulants for the muscle biopsy after physician review), recent gastrointestinal bleeding (<3 months) advanced organ diseases: congestive heart failure (nyha class 3 and 4), chronic obstructive pulmonary diseases (copd) (gold stage 3 and 4), chronic kidney disease (cr>3), metastatic malignancy medications that alter muscle protein metabolism except systemic corticosteroids pregnancy unwillingness/ inability to sign informed consent |
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Number of arms
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
The Cleveland Clinic |
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Inclusion age min
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
21 |
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Inclusion age max
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
48 |
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primary outcome
Last imported at : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Change in skeletal muscle mass at Day 0 and Day 90;Number of hospital admissions between Day 0 and Day 90 |
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Notes
Last imported at : April 28, 2021, 12:31 a.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 : April 28, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1401, "treatment_name": "\u0392-hydroxy \u03b2-methyl butyrate (hmb) enriched amino acid", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 176, "treatment_name": "Balanced amino acid", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}] |