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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637906
• Other study ID #: Bioarginina
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: September 18, 2021

Study information

• Verified date: March 2021
• Source: University of Campania "Luigi Vanvitelli"
• Contact: barbara maglione
• Phone: 3343293357
• Email: bmaglione[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: September 18, 2021
• Est. primary completion date: April 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Dietary Supplement:
• Bioarginina®
Food supplement based on 1,66 grams of L-arginine

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Specialistica Dei Colli	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of P / F normalization times	Alveolar pressure of oxygen / inspiratory fraction of oxygen	60 days