ALACOVID Study for Vaccinated Subjects (COVID-19)

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Respiratory Infection
• Intervention / Treatment: Drug: 150 mg 5-ALAPhosphate + SFC; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Dombivli, Maharashtra, India, 421203
      • BAJ RR Hospital and Research Centre
    • Nashik, Maharashtra, India, 422005
      • Leelawati Care Hospital-Nasik (SMO)
    • Pune, Maharashtra, India, 411037
      • Ranka Hospital
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • JNU Institute for Medical Sciences and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; No Description for the intervention
Experimental: 150 mg 5-ALAPhosphate + SFC; 2 capsules in the morning after breakfast (before 11 AM) and 1 capsule in the evening after a snack or after dinner (before 8 PM) orally with water for 21 days.	Drug: 150 mg 5-ALAPhosphate + SFC; 2 capsules in the morning after breakfast (before 11 AM) and 1 capsule in the evening after a snack or after dinner (before 8 PM) orally with water for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse product reaction	To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.	Day 0
Adverse product reaction	To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.	Day 1
Adverse product reaction	To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.	Day 7
Adverse product reaction	To determine the safety of 21 days oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 vaccine.	Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change in GMT of IgG levels against Covid-19 spike protein	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 study (day 21).	Day 0 and Day 21
European Quality of Life Five Dimension Five level questionnaire	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 problems. The subject is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the subject's health state. The Lower level is denoted as 1 and the highest level is denoted as 5. The EQ-5D-5L QoL questionnaire will be completed by the subject.	Day 0 , Day 1, Day 7 and Day 21
World Health Organization Well-Being Index questionnaire	The 5-item World Health Organization Well-Being Index (WHO-5) is a short and generic global rating scale measuring subjective well-being.	Day 0 , Day 1, Day 7 and Day 21
Visual Analogue Scale for pain and fatigue	The subjects is asked to place a line perpendicular to the VAS line at the point that represents their current situation for pain and fatigue (question 4). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity	Day 0 , Day 1, Day 7 and Day 21

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): June 18, 2022
• Study Completion (Actual): June 18, 2022

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: PH/210904/5ALP/COVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No