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
试验速览
- 阶段
- 不适用
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Reduction of P / F normalization times
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Reduction of P / F normalization times
时间窗: 60 days
Alveolar pressure of oxygen / inspiratory fraction of oxygen
次要结局
未报告次要终点
研究者
giuseppe fiorentino
PROFESSOR
University of Campania "Luigi Vanvitelli"