search
Back to results

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

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bioarginina®
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Azienda Ospedaliera Specialistica Dei ColliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

L-arginine

Placebo

Arm Description

Bioarginina®, 2 orally administered vials per day

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

Outcomes

Primary Outcome Measures

Reduction of P / F normalization times
Alveolar pressure of oxygen / inspiratory fraction of oxygen

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
March 15, 2021
Sponsor
University of Campania "Luigi Vanvitelli"
search

1. Study Identification

Unique Protocol Identification Number
NCT04637906
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
April 18, 2021 (Anticipated)
Study Completion Date
September 18, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-arginine
Arm Type
Experimental
Arm Description
Bioarginina®, 2 orally administered vials per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 orally administered vials per day of Bioarginina® without L-arginine
Intervention Type
Dietary Supplement
Intervention Name(s)
Bioarginina®
Intervention Description
Food supplement based on 1,66 grams of L-arginine
Primary Outcome Measure Information:
Title
Reduction of P / F normalization times
Description
Alveolar pressure of oxygen / inspiratory fraction of oxygen
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
barbara maglione
Phone
3343293357
Ext
3343293357
Email
bmaglione@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Fiorentino
Organizational Affiliation
Università degli Studi della Campania Luigi Vanvitelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Specialistica Dei Colli
City
Napoli
ZIP/Postal Code
80123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
barbara maglione
Phone
3343293357
Email
bmaglione@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34522871
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. Erratum In: EClinicalMedicine. 2022 Sep 13;51:101636.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs