Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With COVID-19 (SARS-CoV-2)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Randomized, Parallel Group, Double-blind Placebo-controlled Clinical Trial

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: Bioarginina®


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-arginine<br>Bioarginina®, 2 orally administered vials per day | Dietary Supplement: Bioarginina®<br>* Food supplement based on 1,66 grams of L-arginine<br>|
| Placebo Comparator: Placebo<br>2 orally administered vials per day of Bioarginina® without L-arginine | Dietary Supplement: Bioarginina®<br>* Food supplement based on 1,66 grams of L-arginine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of P / F normalization times | Alveolar pressure of oxygen / inspiratory fraction of oxygen | 60 days |