Short and Long-term Effects of Adding Oral L-arginine to Standard Therapy in Patients With COVID-19 (SARS-CoV-2)
1 other identifier
interventional
290
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2020
CompletedStudy Start
First participant enrolled
November 18, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2021
CompletedMarch 16, 2021
March 1, 2021
5 months
November 18, 2020
March 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of P / F normalization times
Alveolar pressure of oxygen / inspiratory fraction of oxygen
60 days
Study Arms (2)
L-arginine
EXPERIMENTALBioarginina®, 2 orally administered vials per day
Placebo
PLACEBO COMPARATOR2 orally administered vials per day of Bioarginina® without L-arginine
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliera Specialistica Dei Colli
Napoli, 80123, Italy
Related Publications (1)
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.
PMID: 34522871DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Fiorentino
University of Campania Luigi Vanvitelli
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROFESSOR
Study Record Dates
First Submitted
November 18, 2020
First Posted
November 20, 2020
Study Start
November 18, 2020
Primary Completion
April 18, 2021
Study Completion
September 18, 2021
Last Updated
March 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share