ALACOVID Study for Vaccinated Subjects

NCT05234346 | Completed

• 1 other identifier: PH/210904/5ALP/COVID
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Absolute change in GMT of IgG levels against Covid-19 spike protein

  Day 0 and Day 21

• European Quality of Life Five Dimension Five level questionnaire

  Day 0 , Day 1, Day 7 and Day 21

• World Health Organization Well-Being Index questionnaire

  Day 0 , Day 1, Day 7 and Day 21

• Visual Analogue Scale for pain and fatigue

  Day 0 , Day 1, Day 7 and Day 21

Study Arms (2)

150 mg 5-ALAPhosphate + SFC

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

150 mg 5-ALAPhosphate + SFC DRUG

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.

150 mg 5-ALAPhosphate + SFC

Placebo OTHER

No Description for the intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male \& female aged ≥ 18 years and ≤70 years.
• 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)
• 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)
• Subject willing and able to provide a written informed consent

You may not qualify if:

• Subjects with anemia (male: \<12 g/dl, females: \<11 g/dl)
• Subjects with more than 2.5 times upper limit of ALT \& AST parameters.
• Subjects not willing to stop intake of any vitamin/s or mineral/s supplements during the trial except for those allowed in the study.
• Subjects with acute symptomatic COVID-19 infection indicated by fever, dry cough and severe respiratory distress.
• Subjects with SpO2 \< 90%.
• Subjects with history of genetic disorders.
• Subjects with history of:
• Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
• Immediate or delayed-onset anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items etc.
• 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
• Provisional / temporary contraindications:
• Persons having active symptoms of SARS-CoV-2 infection.
• SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma
• Signs of acute infection or illness

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (4)

BAJ RR Hospital and Research Centre

Dombivali, Maharashtra, 421203, India

Location

Leelawati Care Hospital-Nasik (SMO)

Nashik, Maharashtra, 422005, India

Location

Ranka Hospital

Pune, Maharashtra, 411037, India

Location

JNU Institute for Medical Sciences and Research Centre

Jaipur, Rajasthan, 302017, India

Location

MeSH Terms

Interventions

Sodium Glutamate

Intervention Hierarchy (Ancestors)

Glutamic Acid; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An Open-Label, Pilot Study

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 10, 2022
• Study Start: March 15, 2022
• Primary Completion: June 18, 2022
• Study Completion: June 18, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-05

Locations

IN (4)