| Trial registration number
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NCT04637906 |
Full text link
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04637906
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First author
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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barbara maglione
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Contact
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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bmaglione@hotmail.com
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Registration date
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2020-11-20
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Recruitment status
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 23, 2020, 12:31 a.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. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- age> 18 years
- diagnosis of covid 19, confirmed by rt-pcr on a nasopharyngeal swab
- covid 19 pneumonia with the following clinical characteristics: spo2 in ambient air
<93% and alveolar pressure of oxygen / inspiratory fraction of oxygen (pao2 / fio2 - p
/ f <300 mmhg.
- lymphocytopenia defined as lymphocytes <1500 / mcl or <20% of white blood cells
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Exclusion criteria
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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- history of intolerance to l-arginine
- severe chronic pulmonary disease
- pregnancy or breastfeeding
- neutropenia due to neoplasms of the haematopoietic system or other organs with
invasion of the bone marrow
- use of immunosuppressive drugs or cytotoxic chemotherapies within the previous three
weeks
- refusal to give consent to participate in the study
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Number of arms
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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University of Campania "Luigi Vanvitelli"
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Inclusion age min
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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19
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Inclusion age max
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : Jan. 20, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Italy
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Type of patients
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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290
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primary outcome
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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Reduction of P / F normalization times
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Notes
Last imported at : Nov. 23, 2020, 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 : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 714, "treatment_name": "L-arginine", "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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