Evaluation of the Efficacy and Safety of Nano-S1 in Adult Patients Infected With SARS-Cov-2: "COVID Nano-S1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Clinical evolution
研究概览
简要总结
This study aims to assess the efficacy of the efficacy and safety of investigational drug (NanoS) in patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19, including death.
详细描述
We conducted a prospective randomized double-blind clinical trial over five months to determine the efficacy of NanoS compared to placebo. The effectiveness of treatment was measured by the significant decline in the number of cases of covid-19 infection and/or a decrease in the viral load determined by SARS-CoV-2 cycle threshold (Ct) value using RT-PCRs test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are hospitalized in a COVID unity or outpatient follow-up by the investigator
- •Participants who have positive SARS-CoV-2 test result and the onset of symptoms of COVID-19 ≤7 days prior to randomization, Not exceed the 7th day since the beginning of disease symptoms; and the randomization's day.
- •Present at least one of these symptoms: Participants who have one or more mild or moderate COVID-19 symptoms: Fever, general signs such as: headaches, asthenia, myalgia, arthralgia, etc... ENT signs such as: Sore throat, anosmia, agueusia, hypoacusis, deafness, etc... Digestive signs such as: diarrhea, vomiting, abdominal pain, etc... Respiratory signs such as: dyspnea, cough, etc... And cutaneous signs such as: skin rash, livedo, etc...
- •Present an oxygen saturation patients with SpO2 > 94% at room air
- •Present at least one of these risk factors:
- •Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death: Age 65 years old Or -Age between 18 and 64 years old with at least one of these risk factors: Obesity (BMI> 30 kg/m2),and/or diabetes under treatment and/or cardiovascular disease (including hypertension and stable angina) high blood pressure
- •and/or Chronic obstructive pulmonary disease (COPD) disease and/or asthma and/or Neoplasia (solid tumour; hematological malignancy) neoplasia, and/or a blood disease and/or heart failure and/or chronic renal failure (Cl creat> 30Mml/min) and/or unstabe angina and/or autoimmune disease.
- •Have signed the informed consent to participate in this trial.
排除标准
- •Non observance.Non-compliant patient With drawal of Consent. Patient who refuses blood samples.
研究组 & 干预措施
A bras actif
The experimental arm has received the Nanos product orally with a dose of 30mL, 3 times per day and away from meals (2 hours after a meal or on an empty stomach).
干预措施: NANOS1 , argent colloïdal , (Drug)
B bras controle
The placebo arm has received the Nanos product orally with a dose of 30mL, 3 times per day and away from meals (2 hours after a meal or on an empty stomach).
干预措施: NANOS1 , argent colloïdal , (Drug)
结局指标
主要结局
Clinical evolution
时间窗: 14DAY
The evolution clinical state of evaluated patient clinical state after 14 days since the beginning of the disease is made with " a 8-point ordinal scale " (WHO Rd Blue print novel Coronavirus / COVID-19 Therapeutic Trial Synopsis / 18 February 2020)
次要结局
- Negativation of the RT- PCR(DAY 14)
- Systemic passage(DAY 30)
- Disappearance of clinical signs(3 days)
- Viral load Ct value(admission ,DAY6, DAY14)
- Tolerance(DAY 14, DAY 30)