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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04854876
Recruitment Status : Withdrawn (The food supplement/health product registration needs to be undertaken with NHRA- Pharmaceutical Product Regulations Department)
First Posted : April 22, 2021
Last Update Posted : September 22, 2021
Sponsor:
Collaborator:
Bahrain Defence Force Hospital
Information provided by (Responsible Party):
Royal College of Surgeons in Ireland - Medical University of Bahrain

Study Description
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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 infection to define the safety and to activate the immune system during SARS-CoV-2 vaccination.

The primary objective of this study is to determine the safety of a 4 week daily oral administration of 5-ALA-Phosphate + SFC in subjects vaccinated with COVID-19 Vaccine


Condition or disease Intervention/treatment Phase
SARS-COV 2 Covid19 Dietary Supplement: 5-ALA-Phosphate + SFC (5-ALA+SFC) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open-label, two arm interventional exploratory study, in which one arm will consist of 100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) and those will be treated with 150mg 5-ALA Phosphate/SFC for 28 days. The second arm will consist of 100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only (Control). This is to determine the safety and evaluate the efficacy of 5-ALA-Phosphate-SFC during the vaccination of subjects against SARS-CoV-2 (COVID-19) virus infection and to activate the immune system during SARS-CoV-2 vaccination.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 15, 2021
Actual Primary Completion Date : August 30, 2021
Actual Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccinated with 1st dose of COVID-19 Vaccine & treated with 5-ALA Phosphate/SFC
100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) and that will be treated with 150mg 5-ALA Phosphate/SFC for 28 days
 Dietary Supplement: 5-ALA-Phosphate + SFC (5-ALA+SFC)
The food supplement 5-Aminolevulinic acid phosphate and Sodium ferrous citrate (5-ALA-Phosphate + SFC) will be administered orally daily for 28 days. The dose will be in total 3 capsules of 50 mg 5-ALA-Phosphate and 28.68 mg SFC (3.04 mg as Fe) per day, 2 capsules in the morning and 1 capsule in the evening resulting in 150 mg 5-ALA-Phosphate and 86.04 mg SFC ( 9.12 mg as Fe).
No Intervention: Vaccinated with 1st dose of COVID-19 Vaccine
100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only (Control)


Outcome Measures
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Primary Outcome Measures :
  1. To determine the safety of a 4 week daily oral administration of 5-ALA + SFC in subject vaccinated with COVID-19 Vaccine [ Time Frame: 28 days ]
    To capture the incidence of all treatment emergent AEs and SAEs Grade III and IV (CTC) with reasonable possibility of causal relationship to 5-ALA + SFC


Secondary Outcome Measures :
  1. To evaluate the efficacy of 5-ALA + SFC in activating the immune system in subject vaccinated with COVID-19 Vaccine [ Time Frame: 28 days ]
    To determine the serum levels of biomarkers (CD4+/- and CD8+/- ) before and after vaccination with and without 5-ALA + SFC administration and total antibody level and neutralizing antibody level


Other Outcome Measures:
  1. Measurement of total IgA, IgM and IgG antibodies against SARS-CoV 2 [ Time Frame: 28 days ]
    To determine measurement of total IgA, IgM and IgG antibodies against SARS-CoV 2 before and after vaccination with and without 5-ALA + SFC administration

  2. Clinical laboratory assessments (hepatic function) [ Time Frame: 28 days ]
    Monitoring of the liver enzymes before and during the study


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854876


Sponsors and Collaborators
Royal College of Surgeons in Ireland - Medical University of Bahrain
Bahrain Defence Force Hospital
Investigators
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Principal Investigator: Abdulla Darwish, Dr Bahrain Defense Force Royal Medical Services, Military Hospital
More Information
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Publications:
Brooks A., Study 8259980 "5-ALA/SFC: A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Caucasian and Japanese Subjects," Covance: Leeds and London, UK (2013)
Hu X. 5-Aminolevulinic acid with sodium ferrous citrate enhance the antitumor effects of PD-L1 blockade in mouse melanoma model7th International ALA and Prophyrin Symposium (IAPS7) in Sapporo 2019.
Investigator's Brochure, SBI Pharmaceuticals Internal Document: 5-Aminolevulinic Acid (5-ALA) Phosphate Version 1.0. July, 2020
Matsumoto C., Study ALA-01 "Bioequivalence study of test foods A, B, and C - Based on the Plasma Concentration of 5-Aminolevulinic Acid." Kaiyu Clinic: Tokyo Japan (2010)
Ripperger T. J. et al., Detection, prevalence, and duration of humoral responses to SARS-CoV-2 under conditions of limited population exposure. medRxiv, (2020).
Bilich T., Nelde A., Heitmann J.S., Maringer Y., Roerden M., Bauer J., Rieth J., Wacker M., Peter A., Hörber S., Rachfalski D., Märklin M., Stevanovic A., Rammensee G., Salih H.R., Walz J.S. Differential kinetics of T cell and antibody responses delineate dominant T cell epitopes in long-term immunity after COVID-19, DOI: https://doi.org/10.21203/rs.3.rs-114499/v1

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Responsible Party: Royal College of Surgeons in Ireland - Medical University of Bahrain
ClinicalTrials.gov Identifier: NCT04854876    
Other Study ID Numbers: BDF/R&REC/2021-566
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal College of Surgeons in Ireland - Medical University of Bahrain:
5-ALAPhosphate + SFC
COVID-19 Vaccination
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases