NCT05234346已完成不适用
An Open-Label, Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC as an Immune System Enhancer Along With Vaccination Against SARS-CoV-2 Virus Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Adverse product reaction
研究概览
简要总结
In this study, it is hypothesized that administration of 5-ALA-Phosphate + SFC in subjects vaccinated against Covid-19 could contribute in enhancing the targeted function of the immune system, which might lead to re-activation and/or increase of the vaccination response. Thus, in the present study, we will be evaluating the safety and efficacy of 5-ALA-Phosphate + SFC in subjects receiving the Covid-19 vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female aged ≥ 18 years and ≤70 years.
- •Subjects with documented proof of 1st dose of vaccination within 3 months of planned 2nd dose. (If government of India implements booster dose then subjects needs to have a documented proof of 2nd dose)
- •Subjects planning to have 2nd /3rd dose of COVID-19 vaccine (Covishield/ Covaxin). (If government of India implements booster dose then subjects planning to have a 3rd dose of vaccine will be included in this study)
- •Subject willing and able to provide a written informed consent
排除标准
- •Subjects with anemia (male: <12 g/dl, females: <11 g/dl)
- •Subjects with more than 2.5 times upper limit of ALT & AST parameters.
- •Subjects not willing to stop intake of any vitamin/s or mineral/s supplements during the trial except for those allowed in the study.
- •Subjects with acute symptomatic COVID-19 infection indicated by fever, dry cough and severe respiratory distress.
- •Subjects with SpO2 < 90%.
- •Subjects with history of genetic disorders.
- •Subjects with history of:
- •Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
- •Immediate or delayed-onset anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items etc.
- •Pregnancy & Lactation:
- •a. Pregnant & Lactating women have not been part of any COVID-19 vaccine clinical trial so far. Therefore, women who are pregnant or not sure of their pregnancy; and lactating women should not receive COVID-19 vaccine at this time
- •Provisional / temporary contraindications:
- •Persons having active symptoms of SARS-CoV-2 infection.
- •SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma
- •Signs of acute infection or illness
- •Hospitalized patients due to any illness.
- •Subjects with known history (diagnosed case) of porphyria, or chronic serious liver disease, kidney disease or heart problems.
- •Subjects with frequent complaints of cold, fever, cough.
- •Subjects with irritable bowel syndrome.
- •Subjects who are frequent travelers or are planning to travel.
- •Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration.
- •Subjects with known allergy to 5-ALA containing foods (spinach, shitake mushroom, octopus, baker's yeast, wine, vinegar, sake less).
- •Subjects on vitamin D supplements
- •Males and females of reproductive potential who have not agreed to use an adequate method of contraception during the study
- •For females, adequate birth control methods will be defined as: hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom
- •+ diaphragm, condom or diaphragm + spermicidal gel or foam.
- •For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
- •For females, menopause is defined as one year without menses; if in question, a follicle-stimulating hormone of >40 U/ml must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable.
- •Subjects who are unable or unwilling to comply with requirements of the clinical trial.
- •Participation in any other clinical trial of an experimental treatment for COVID-
- •Subjects having any other family member participating in this study.
- •Subjects who may be excluded at the Investigator's discretion.
研究组 & 干预措施
150 mg 5-ALAPhosphate + SFC
Experimental
2 capsules in the morning after breakfast (before 11 AM) and 1 capsule in the evening after a snack or after dinner (before 8 PM) orally with water for 21 days.
干预措施: 150 mg 5-ALAPhosphate + SFC (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Adverse product reaction
时间窗: Day 21
To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.
次要结局
- Absolute change in GMT of IgG levels against Covid-19 spike protein(Day 0 and Day 21)
- Visual Analogue Scale for pain and fatigue(Day 0 , Day 1, Day 7 and Day 21)
- European Quality of Life Five Dimension Five level questionnaire(Day 0 , Day 1, Day 7 and Day 21)
- World Health Organization Well-Being Index questionnaire(Day 0 , Day 1, Day 7 and Day 21)
研究者
研究点 (4)
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