| Trial registration number
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NCT04847791 |
Full text link
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04847791
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First author
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Paolo Manzoni, MD
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Contact
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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paolomanzoni@hotmail.com
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Registration date
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-04-19
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Recruitment status
Last imported at : April 6, 2023, 8 p.m.
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : April 22, 2021, 12:31 a.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:
hospitalization in non-icu ward for covid-19 infection, with virological diagnosis sars-cov2 confirmed via rt-pcr (or quick test)
age>18 aa
covid symptomatology story from no more than 12 days
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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refusal of consent
need for immediate admission to intensive care
severe neoplasms (in advanced stage)
allergies or intolerances known to lactoferrin
4. already being treated with lactoferrin at the entrance to the hospital 5. patients with end-stage renal failure (stage 5) 6. extremely serious general conditions to suggest an imminent exitus 7. clinical conditions of absolute impossibility of tolerating ingestion of drugs/capsules due to conditions contraining the initiation of therapy for os.
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Number of arms
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Paolo Manzoni
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Inclusion age min
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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99
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Countries
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Italy
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Type of patients
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : April 22, 2021, 12:31 a.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 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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194
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primary outcome
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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death;intensive care unit hospitalization rate;National Early Warning Score (NEWS);proportion of discharged patients
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Notes
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : April 22, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 227, "treatment_name": "Bovine lactoferrin", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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