Status:
COMPLETED
ALACOVID Study for Vaccinated Subjects
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
COVID-19 Respiratory Infection
Eligibility:
All Genders
18-70 years
Phase:
NA
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 m...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Hospitalized patients due to any illness.
- Subjects with known history (diagnosed case) of porphyria, or chronic serious liver disease, kidney disease or heart problems.
- Subjects with frequent complaints of cold, fever, cough.
- Subjects with irritable bowel syndrome.
- Subjects who are frequent travelers or are planning to travel.
- Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration.
- Subjects with known allergy to 5-ALA containing foods (spinach, shitake mushroom, octopus, baker's yeast, wine, vinegar, sake less).
- Subjects on vitamin D supplements
- Males and females of reproductive potential who have not agreed to use an adequate method of contraception during the study
- 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.
- For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
- 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.
- Subjects who are unable or unwilling to comply with requirements of the clinical trial.
- Participation in any other clinical trial of an experimental treatment for COVID-19.
- Subjects having any other family member participating in this study.
- Subjects who may be excluded at the Investigator's discretion.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05234346
Start Date
March 15 2022
End Date
June 18 2022
Last Update
July 11 2022
Active Locations (4)
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1
BAJ RR Hospital and Research Centre
Dombivali, Maharashtra, India, 421203
2
Leelawati Care Hospital-Nasik (SMO)
Nashik, Maharashtra, India, 422005
3
Ranka Hospital
Pune, Maharashtra, India, 411037
4
JNU Institute for Medical Sciences and Research Centre
Jaipur, Rajasthan, India, 302017