Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-arginine | Experimental | Bioarginina®, 2 orally administered vials per day |
|
| Placebo | Placebo Comparator | 2 orally administered vials per day of Bioarginina® without L-arginine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioarginina® | Dietary Supplement | Food supplement based on 1,66 grams of L-arginine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of P / F normalization times | Alveolar pressure of oxygen / inspiratory fraction of oxygen | 60 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| barbara maglione | Contact | 3343293357 | 3343293357 | bmaglione@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Fiorentino | University of Campania Luigi Vanvitelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Specialistica Dei Colli | Recruiting | Naples | 80123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34522871 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 16, 2021 | |
| Reset | Jun 23, 2021 | |
| Release | Jun 24, 2021 | |
| Reset | Jun 24, 2021 | |
| Release | Sep 20, 2021 | |
| Reset | Sep 22, 2021 | |
| Release | Sep 30, 2021 | |
| Reset | Oct 1, 2021 | |
| Release | May 4, 2022 | |
| Reset | Feb 2, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 16, 2021 | Jun 23, 2021 | |||
| Jun 24, 2021 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Jun 24, 2021 |
| Sep 20, 2021 | Sep 22, 2021 |
| Sep 30, 2021 | Oct 1, 2021 |
| May 4, 2022 | Feb 2, 2023 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |