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

University of Campania "Luigi Vanvitelli"

Status: Unknown

Conditions: Covid19

Treatments: Dietary Supplement: Bioarginina®

Study type: Interventional

Funder types: Other

Identifiers

NCT04637906

Bioarginina

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups, including a placebo group

L-arginine

Experimental group

Description:

Bioarginina®, 2 orally administered vials per day

Treatment:

Dietary Supplement: Bioarginina®

Placebo

Placebo Comparator group

Description:

2 orally administered vials per day of Bioarginina® without L-arginine

Treatment:

Dietary Supplement: Bioarginina®