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

Not Applicable

• Conditions: Covid19
• Interventions: Dietary Supplement: Bioarginina®

• Registration Number: NCT04637906
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Study Timeline

• Study Start: 2020-11-18
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16
• Primary Completion: 2021-04-18
• Study Completion: 2021-09-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-arginine	Bioarginina®	Bioarginina®, 2 orally administered vials per day
Placebo	Bioarginina®	2 orally administered vials per day of Bioarginina® without L-arginine

Primary Outcome Measures

Name	Time	Method
Reduction of P / F normalization times	60 days	Alveolar pressure of oxygen / inspiratory fraction of oxygen

Trial Locations

Locations (1)

Azienda Ospedaliera Specialistica Dei Colli; 🇮🇹 Napoli, Italy