Randomized Trial to Assess the Efficacy and Safety of Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Addition to the Standard of Care (SOC) Compared SOC in the Treatment of Hospitalized With COVID-19 Patients Who Not Requiring the Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- 14-day Participant Mortality
研究概览
简要总结
The SaiseiCovUKR clinical study is a multicentric, randomized trial study targeting patients hospitalized with COVID-19 who do not require mechanical ventilation. This study aims to provide preliminary data on the activity and safety of MAF capsules and M capsules in the target population after 14 days of dosing. MAF capsules and M capsules are dietary supplements targeting the gut's mucosal immunity to control local and systemic inflammation, limiting epithelial damage and preventing the accumulation of pathological macrophage populations at sites of SARS-CoV-2 infection.
详细描述
Saisei Pharma is developing biologics using an enzymatic modification of Vitamin D binding protein and other glycoproteins in biological substrates, which have been shown to increase macrophage phagocytic and antigen processing activity without promoting the proinflammatory profile of macrophages. Bovine colostrum is the substrate for MAF capsules and bovine whey for M capsules. The enteric capsules formulation of the investigational dietary supplements is targeting the gut mucosa and its associated natural anti-inflammatory macrophages profile. The SaiseiCovUKR clinical study is multicentric, randomized, open-label in hospitalized patients with moderate and severe COVID-19 to provide data on the activity and safety of MAF capsules and M capsules in the target population after 14 days of dosing. The trial will use an adaptive design based on a pre-specified criteria, using an independent external Data Monitoring Committee (DMC) to monitor safety, efficacy, and review data at appropriate intervals. The general objectives of the study are to obtain a preliminary indication of activity of MAF capsules and M capsules on shortened time to recovery and decreased mortality in the target population (600 patients, age ≥ 18 years). The study results can provide a background for further investigation of the studied dietary supplements as new drugs in COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients found to have positive RT-PCR for SARS-CoV-2 in any specimen on 4 days prior to randomization, those who are hospitalized with evidence of respiratory disease during clinical assessment or imaging
- •Male or non-pregnant female adult ≥18 years of age subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures
- •Subject (or legally authorized representative) understands and agrees to comply with planned study procedures
- •Has illness of not more than 7 days duration
- •At the time of enrolment does not require immediate resuscitation or mechanical ventilation
- •Respiration rate ≤ 29 per minute
- •SpO2 ≤ 95% on room air
- •Agrees to not participate in another clinical trial through Day 29
排除标准
- •Pregnant or breastfeeding women
- •Known allergy to dairy products
- •On corticosteroids for COVID-19 therapy at the time of screening
- •Subjects who are taking corticosteroids or other immunosuppressive drugs for other medical conditions
- •Concurrent malignancy requiring chemotherapy
- •Known renal insufficiency with glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
- •ALT or AST > 5 times the upper limit of normal
- •Subjects receiving other immune-based therapy for COVID-19, such as convalescent plasma, immunoglobulin products, interferons
结局指标
主要结局
14-day Participant Mortality
时间窗: Day 1 through Day 14
The mortality rate will be determined as the proportion of participants who died by study Day 14
29-day Participant Mortality
时间窗: Day 1 through Day 29
The mortality rate will be determined as the proportion of participants who died by study Day 29
The time to basic clinical improvement and to recovery defined as the following
时间窗: Day 1 through Day 29
* Hospitalized, not requiring supplemental oxygen, requires ongoing medical care * Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care * Not hospitalized, limitation on activities and/or requiring home oxygen * Not hospitalized, no limitations on activities
次要结局
- Time to an improvement of one category from admission on 9-Point Ordinal Scale(Day 1 through Day 29)
- Duration of Non-invasive Ventilation or High Flow Oxygen Use(Day 1 through Day 29)
- Percentage of Participants Requiring New Oxygen Use(Day 1 through Day 29)
- Percentage of participants with post-COVID-19 related symptoms at Day 60(Day 60)
- Change From Baseline in Glucose(Days 1, 7, 14 and 29)
- Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day at days 3, 5, 8, 11,14 and 29(Days 3, 5, 8, 11,14 and 29)
- Duration of conventional oxygen therapy Use(Day 1 through Day 29)
- Duration of new conventional oxygen therapy use(Day 1 through Day 29)
- Incidents of post-COVID-19 related symptoms at Day 29(Day 29)
- Change From Baseline in Total Bilirubin(Days 1, 7, 14 and 29)
- Change From Baseline in Hemoglobin(Days 1, 7, 14 and 29)
- Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14(Day 14)
- Time to an improvement of two categories from admission on 9-Point Ordinal Scale(Day 1 through Day 29)
- Percentage of participants with post-COVID-19 related symptoms at Day 29(Day 29)
- Percentage of Participants Discontinued or Temporarily Suspended From Investigational dietary supplements(Day 1 through Day 14)
- Change From Baseline in Lymphocytes(Days 1, 7, 14 and 29)
- Mean change in the ranking on 9-Point Ordinal Scale from baseline to days 3, 5, 8, 11, 14 and 29(Days 3, 5, 8, 11, 14 and 29)
- Duration of New Non-invasive Ventilation or High Flow Oxygen Use(Day 1 through Day 29)
- Duration of Mechanical Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use(Day 1 through Day 29)
- Percentage of Participants Requiring Ventilator or ECMO Use(Day 1 through Day 29)
- Incidents of post-COVID-19 related symptoms at Day 60(Day 60)
- Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)(Day 1 through Day 29)
- Change From Baseline in Aspartate Transaminase (AST)(Days 1, 7, 14 and 29)
- Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use(Day 1 through Day 29)
- Percentage of Participants Reporting Serious Adverse Events (SAEs)(Day 1 through Day 29)
- Change From Baseline in Alanine Transaminase (ALT)(Days 1, 7, 14 and 29)
- Change From Baseline in Creatinine(Days 1, 7, 14 and 29)
- Change From Baseline in Platelets(Days 1, 7, 14 and 29)
- Change From Baseline in White Blood Cell Count (WBC)(Days 1, 7, 14 and 29)