Covid19
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBioarginina®
Food supplement based on 1,66 grams of L-arginine
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of P / F normalization times | 60 days | Alveolar pressure of oxygen / inspiratory fraction of oxygen |
Countries
Italy
Contacts
Primary Contactbarbara maglione
Outcome results
None listed