CTRI/2022/03/040990招募中未知
An Open-Label, Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate with SFC as an Immune System Enhancer Along With Vaccination Against SARS-CoV-2 Virus Infection
Dr Shalini Srivastava0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male & female aged ââ?°Â¥ 18 years and ââ?°Â¤70 years.
- •2. 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
- •3. 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)
- •4. Subject willing and able to provide a written informed consent.
排除标准
- •1. Subjects with anemia (male: <12 g/dl, females: <11 g/dl)
- •2. Subjects with more than 2.5 times upper limit of ALT & AST parameters.
- •3. Subjects not willing to stop intake of any vitamin/s or mineral/s supplements during the trial except for those allowed in the study.
- •4. Subjects with acute symptomatic COVID-19 infection indicated by fever, dry cough and severe respiratory distress.
- •5. Subjects with SpO2 < 90%.
- •6. Subjects with history of genetic disorders.
- •7. Subjects with history of:
- •a. Anaphylactic or allergic reaction to a previous dose of COVID- 19 vaccine
- •b. Immediate or delayed-onset anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items etc.
- •8. 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.
- •9. Provisional / temporary contraindications:
- •a. Persons having active symptoms of SARS-CoV-2 infection.
- •b. SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma
- •c. Signs of acute infection or illness
- •d. Hospitalized patients due to any illness.
- •10. Subjects with known history (diagnosed case) of porphyria, or acute serious liver disease, kidney disease or heart problems.
- •11. Subjects with frequent complaints of cold, fever, cough.
- •12. Subjects with irritable bowel syndrome.
- •13. Subjects who are frequent travelers or are planning to travel.
- •14. Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration.
- •15. Subjects with known allergy to 5-ALA containing foods (spinach, shitake mushroom, octopus, bakerââ?¬•s yeast, wine, vinegar, sake less).
- •16. Subjects on vitamin D supplements
- •17. Males and females of reproductive potential who have not agreed to use an adequate method of contraception during the study
- •a. 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.
- •b. For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
- •c. 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.
- •18. Subjects who are unable or unwilling to comply with requirements of the clinical trial.
- •19. Participation in any other clinical trial of an experimental treatment for COVID-19.
- •20. Subjects having any other family member participating in this study.
- •21. Subjects who may be excluded at the Investigatorââ?¬•s discretion
研究者
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