Study of Enhancer Along With Vaccination Against SARS-CoV-2 Virus Infectio

Not Applicable

• Registration Number: CTRI/2022/03/040990
• Lead Sponsor: Dr Shalini Srivastava

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male & female aged � 18 years and �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

dose).

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.

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:

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse product reaction <br/ ><br>To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccineTimepoint: Day 0 , Day 1, Day 7 and Day 21

Secondary Outcome Measures

Name	Time	Method
Absolute change in GMT of IgG levels against Covid-19 spike protein <br/ ><br>Elecsys Anti-SARS-CoV-2 S kit will be used to measure the levels of IgG post vaccination on baseline and at the end of the studyTimepoint: Day 0 and Day 21;European Quality of Life Five Dimension Five level questionnaire <br/ ><br>The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problemsTimepoint: Day 0 , Day 1, Day 7 and Day 21;Visual Analogue Scale for pain and fatigueTimepoint: Day 0 , Day 1, Day 7 and Day 21;World Health Organization Well-Being Index questionnaire <br/ ><br>The 5-item World Health Organization Well-Being Index (WHO-5) is a short and generic global rating scale measuring subjective well-being.Timepoint: Day 0 , Day 1, Day 7 and Day 21