Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Symptom resolution
研究概览
简要总结
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
详细描述
This is a two-arm, randomized, open label, two-center, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
A total of 60 subjects will be randomized 2:1 in this study. 40 patients will be assigned to receive daily oral doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours and standard care. Other 20 patients will be assigned to receive only standard care.
Treatment duration: 21 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults aged ≥18 years at the time of enrollment.
- •Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
- •Mild (uncomplicated) Illness:
- •Diagnosed with COVID-19 by a standardized RT-PCR assay and
- •Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath and
- •No signs of a more serious lower airway disease and
- •RR<20, HR <90, oxygen saturation (pulse oximetry) > 93% on room air
- •Moderate Illness:
- •Diagnosed with COVID-19 by a standardized RT-PCR assay and
- •In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) or
- •Signs of moderate pneumonia, including RR ≥ 20 but <30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) > 93% on room air and
- •If available, lung infiltrates based on X-ray or CT scan < 50% present
- •Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered not clinically significant by the Principal Investigator.
- •Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- •Understands and agrees to comply with planned study procedures.
排除标准
- •Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening.
- •History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
- •Subjects showing signs of clinical jaundice at the time of screening.
- •History of moderate and severe liver disease (Child-Pugh score >12).
- •Subjects requiring Renal Replacement Therapy (RRT) at the time of screening.
- •History of uncontrolled diabetes.
- •History of severe chronic kidney disease or requiring dialysis.
- •Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.
- •Patients with malignant tumor, or other serious systemic diseases.
- •Patients who are participating in other clinical trials.
- •Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Viusid or Asbrip are not eligible.
- •Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the study.
研究组 & 干预措施
Interventional
A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital.
Treatment duration: 21 days.
干预措施: Viusid (Dietary Supplement)
Interventional
A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital.
Treatment duration: 21 days.
干预措施: Asbrip (Dietary Supplement)
Interventional
A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip, plus standard care of the hospital.
Treatment duration: 21 days.
干预措施: Standard Care (Drug)
Control
A total of 60 subjects will be randomized 2: 1 in this study. 20 control patients will be assigned to standard care of the hospital only.
Treatment duration: 21 days.
干预措施: Standard Care (Drug)
结局指标
主要结局
Symptom resolution
时间窗: 21 days
Symptom resolution of COVID-19 disease The number of days required to reach symptom score \<0,25 for each one of four symptom category mentioned before.
Time to semirecover
时间窗: 21 days
Efficacy will be determined by the number of days required to reach a 50 percent reduction in the composite score, i.e. "time to semirecovery" (primary outcome measure).
Clinical Improvement
时间窗: 21 days
Clinical Improvement as assessed by change in total symptom score ranging from 0-12. The symptom score includes: \[everyday assessment, up to 21 days\]. 1. Fever (temperature in oC) based on a scale 0-3: 0 \<36,7; 1 =36,7-37,8; 2 =37,8-38,9; 3 \> 38,9. 2. Cough on a scale 0-3: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe. 3. Shortness of breath based on a scale 0-3: 0 = no shortness of breath, 1 = with moderate intensity exercise, 2 = with walking on flat surface, 3 = short of breath with getting dressed or daily activities. 4. Fatigue on a 0-3 scale: 0 = no fatigue, 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue. Composite score is a sum of mentioned four symptom scores, assessed every day up to 21 days. It ranges from 0 to 12.
Time to recovery
时间窗: 21 days
Time (days) to recovery from COVID-19 disease The number of days required to reach composite score \<1.
次要结局
- Mortality rate(21 days)
- Incidence of oxygen use(21 days)
- Incidence of hospitalization(21 days)
- Incidence of mechanical ventilation supply(21 days)
- Duration of SARS-CoV-2 PCR positivity(21 days)
- Concentration of C-reactive protein in peripheral blood(21 days)
- Duration (days) of hospitalization(21 days)
- Duration (days) of oxygen use(21 days)
- Cumulative assessment of disease severity(21 days)