ALACOVID Study for Vaccinated Subjects

Exclusion Criteria

• •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:
• •1. Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
• •2. 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:
• •1. Persons having active symptoms of SARS-CoV-2 infection.
• •2. SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma
• •3. Signs of acute infection or illness
• •4. Hospitalized patients due to any illness.
• •10. Subjects with known history (diagnosed case) of porphyria, or chronic 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, baker'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
• •1. 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.
• •2. For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
• •3. 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 Investigator's discretion.