Single-center study with a parallel group scheme, double-blind, randomized, placebo-controlled, to evaluate whether the addition to the investigator's hospital standard therapy of two vials of Bioarginina® per day in subjects with SARS-CoV-2 is useful for treatment of this pathology.
Preliminary experiences conducted in patients affected by SARS-CoV-2 infection by adding the
daily oral administration of two vials of Bioarginina® to the standard therapy have shown
favorable effects on discharge times, on the recovery of the number of lymphocytes and on the
P \ F ratio between arterial pO2 and FiO2 breathed. In particular, for the latter parameter
there is almost a doubling of the recovery speed.
The investigators therefore, decided to undertake the present spontaneous, single-center
study with a parallel group scheme, double-blind randomized, placebo-controlled to evaluate
whether the addition to the standard therapy of two vials per day of Bioarginina® in subjects
of our hospital suffering from SARS-CoV-2 is useful for the treatment of this pathology.
Dietary Supplement: Bioarginina®
Food supplement based on 1,66 grams of L-arginine
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
Exclusion Criteria:
- 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
Azienda Ospedaliera Specialistica Dei Colli
Napoli, Italy
Investigator: barbara maglione
Contact: 3343293357
bmaglione@hotmail.com
barbara maglione
3343293357 - 3343293357
bmaglione@hotmail.com
Giuseppe Fiorentino, Principal Investigator
Università degli Studi della Campania Luigi Vanvitelli