Clinical trial NCT05234346: ALACOVID Study for Vaccinated Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Respiratory Infection
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: An Open-Label, Pilot Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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:

   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.

Primary outcomes:
measure: Adverse product reaction
timeFrame: Day 0
measure: Adverse product reaction
timeFrame: Day 1
measure: Adverse product reaction
timeFrame: Day 7
measure: Adverse product reaction
timeFrame: Day 21
Secondary outcomes:
measure: Absolute change in GMT of IgG levels against Covid-19 spike protein
timeFrame: Day 0 and Day 21
measure: European Quality of Life Five Dimension Five level questionnaire
timeFrame: Day 0 , Day 1, Day 7 and Day 21
measure: World Health Organization Well-Being Index questionnaire
timeFrame: Day 0 , Day 1, Day 7 and Day 21
measure: Visual Analogue Scale for pain and fatigue
timeFrame: Day 0 , Day 1, Day 7 and Day 21
Other outcomes:
Locations:
city: Dombivli
country: India
facility: BAJ RR Hospital and Research Centre
state: Maharashtra
city: Nashik
country: India
facility: Leelawati Care Hospital-Nasik (SMO)
state: Maharashtra
city: Pune
country: India
facility: Ranka Hospital
state: Maharashtra
city: Jaipur
country: India
facility: JNU Institute for Medical Sciences and Research Centre
state: Rajasthan
Study officials:
References: