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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- To determine the safety of a 4 week daily oral administration of 5-ALA + SFC in subject vaccinated with COVID-19 Vaccine
研究概览
简要总结
This is an open-label, two arm interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate-SFC during the vaccination of subjects against SARS-CoV-2 (COVID-19) virus infection to define the safety and to activate the immune system during SARS-CoV-2 vaccination.
The primary objective of this study is to determine the safety of a 4 week daily oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 Vaccine
详细描述
This is an open-label, two arm interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate-SFC during the vaccination of subjects against SARS-CoV-2 (COVID-19) virus infection to define the safety and to activate the immune system during SARS-CoV-2 vaccination.
Arm 1: 100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) and that will be treated with 150mg 5-ALA Phosphate/SFC for 28 days and
Arm 2: 100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only (Control)
The duration of this clinical study will depend on the type of the vaccine, the subject was administered with.
Primary Endpoints: All treatment emergent AEs and SAEs Grade III and IV (CTC) with reasonable possibility of causal relationship to 5-ALA-Phosphate + SFC
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- •Aged ≥ 21 years (at all sites)
- •Subjects that have been vaccinated with the first dose of a vaccine (any brand approved in Bahrain is permitted) to protect against COVID-19 infection
排除标准
- •Subject has acute or chronic type(s) of porphyria or a family history of porphyria.
- •Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration (except for photosensitivity)
- •Pregnant or nursing women
- •Males and females of reproductive potential who have not agreed to use an adequate method of contraception during the study.
- •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-19
- •Subjects who may be excluded at the Investigator's discretion
结局指标
主要结局
To determine the safety of a 4 week daily oral administration of 5-ALA + SFC in subject vaccinated with COVID-19 Vaccine
时间窗: 28 days
To capture the incidence of all treatment emergent AEs and SAEs Grade III and IV (CTC) with reasonable possibility of causal relationship to 5-ALA + SFC
次要结局
- To evaluate the efficacy of 5-ALA + SFC in activating the immune system in subject vaccinated with COVID-19 Vaccine(28 days)