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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04637906
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
giuseppe fiorentino, 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.

Condition or disease Intervention/treatment Phase
Covid19 Dietary Supplement: Bioarginina® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : April 18, 2021
Estimated Study Completion Date : September 18, 2021


Arm Intervention/treatment
Experimental: L-arginine
Bioarginina®, 2 orally administered vials per day
Dietary Supplement: Bioarginina®
Food supplement based on 1,66 grams of L-arginine

Placebo Comparator: Placebo
2 orally administered vials per day of Bioarginina® without L-arginine
Dietary Supplement: Bioarginina®
Food supplement based on 1,66 grams of L-arginine




Primary Outcome Measures :
  1. Reduction of P / F normalization times [ Time Frame: 60 days ]
    Alveolar pressure of oxygen / inspiratory fraction of oxygen



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04637906


Contacts
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Contact: barbara maglione 3343293357 ext 3343293357 bmaglione@hotmail.com

Locations
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Italy
Azienda Ospedaliera Specialistica Dei Colli Recruiting
Napoli, Italy, 80123
Contact: barbara maglione    3343293357    bmaglione@hotmail.com   
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
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Principal Investigator: Giuseppe Fiorentino Università degli Studi della Campania Luigi Vanvitelli
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: giuseppe fiorentino, PROFESSOR, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT04637906    
Other Study ID Numbers: Bioarginina
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases