Clinical trial NCT04637906: Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With COVID-19 (SARS-CoV-2)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 290
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of P / F normalization times
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Azienda Ospedaliera Specialistica Dei Colli
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Giuseppe Fiorentino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiorentino G, Coppola A, Izzo R, Annunziata A, Bernardo M, Lombardi A, Trimarco V, Santulli G, Trimarco B. Effects of adding L-arginine orally to standard therapy in patients with COVID-19: A randomized, double-blind, placebo-controlled, parallel-group trial. Results of the first interim analysis. EClinicalMedicine. 2021 Oct;40:101125. doi: 10.1016/j.eclinm.2021.101125. Epub 2021 Sep 9.