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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-09-18

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.

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-arginine

Bioarginina®, 2 orally administered vials per day

Group Type EXPERIMENTAL

Bioarginina®

Intervention Type DIETARY_SUPPLEMENT

Food supplement based on 1,66 grams of L-arginine

Placebo

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

Group Type PLACEBO_COMPARATOR

Bioarginina®

Intervention Type DIETARY_SUPPLEMENT

Food supplement based on 1,66 grams of L-arginine

Interventions

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Bioarginina®

Food supplement based on 1,66 grams of L-arginine

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No