Status:
WITHDRAWN
Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC as an Immune System Enhancer Along With Vaccination Against COVID-19
Lead Sponsor:
Royal College of Surgeons in Ireland - Medical University of Bahrain
Collaborating Sponsors:
Bahrain Defence Force Hospital
Conditions:
SARS-COV 2
Covid19
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This is an open-label, two arm interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate-SFC during the vaccination of subjects against SARS-CoV-2 (COVID-19) virus infect...
Detailed Description
This is an open-label, two arm interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate-SFC during the vaccination of subjects against SARS-CoV-2 (COVID-19) virus infect...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- Aged ≥ 21 years (at all sites)
- Subjects that have been vaccinated with the first dose of a vaccine (any brand approved in Bahrain is permitted) to protect against COVID-19 infection
Exclusion
- Subject has acute or chronic type(s) of porphyria or a family history of porphyria.
- Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration (except for photosensitivity)
- Pregnant or nursing women
- Males and females of reproductive potential who have not agreed to use an adequate method of contraception during the study.
- 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 who may be excluded at the Investigator's discretion
Key Trial Info
Start Date :
August 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04854876
Start Date
August 15 2021
End Date
August 30 2021
Last Update
September 22 2021
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