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ALACOVID Study for Vaccinated Subjects | Clinical Trials | Clareo Health

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ALACOVID Study for Vaccinated Subjects

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

NCT05234346•Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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:
+22 more criteria

Locations (4)

BAJ RR Hospital and Research Centre

Dombivali, Maharashtra, India

Leelawati Care Hospital-Nasik (SMO)

Nashik, Maharashtra, India

Ranka Hospital

Pune, Maharashtra, India

JNU Institute for Medical Sciences and Research Centre

Jaipur, Rajasthan, India

Key Dates

Start Date

March 15, 2022

Primary Completion Date

June 18, 2022

Completion Date

June 18, 2022

Last Updated

July 11, 2022

Enrollment

200

ACTUAL participants

Conditions

COVID-19 Respiratory Infection

Interventions

150 mg 5-ALAPhosphate + SFC

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ALACOVID Study for Vaccinated Subjects

Inclusion Criteria

Exclusion Criteria

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