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
Primary Purpose
SARS-COV 2, Covid19
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
5-ALA-Phosphate + SFC (5-ALA+SFC)
Sponsored by
About this trial
This is an interventional prevention trial for SARS-COV 2 focused on measuring 5-ALAPhosphate + SFC, COVID-19 Vaccination
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- Aged β₯ 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vaccinated with 1st dose of COVID-19 Vaccine & treated with 5-ALA Phosphate/SFC
Vaccinated with 1st dose of COVID-19 Vaccine
Arm Description
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
100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only (Control)
Outcomes
Primary Outcome Measures
To determine the safety of a 4 week daily oral administration of 5-ALA + SFC in subject vaccinated with COVID-19 Vaccine
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
To evaluate the efficacy of 5-ALA + SFC in activating the immune system in subject vaccinated with COVID-19 Vaccine
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
Full Information
NCT ID
NCT04854876
First Posted
April 21, 2021
Last Updated
September 15, 2021
Sponsor
Royal College of Surgeons in Ireland - Medical University of Bahrain
Collaborators
Bahrain Defence Force Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04854876
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The food supplement/health product registration needs to be undertaken with NHRA- Pharmaceutical Product Regulations Department
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons in Ireland - Medical University of Bahrain
Collaborators
Bahrain Defence Force Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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 infection to define the safety and to activate the immune system during SARS-CoV-2 vaccination.
Arm 1: 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 and
Arm 2: 100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only (Control)
The duration of this clinical study will depend on the type of the vaccine, the subject was administered with.
Primary Endpoints: All treatment emergent AEs and SAEs Grade III and IV (CTC) with reasonable possibility of causal relationship to 5-ALA-Phosphate + SFC
Secondary Endpoint:
Serum levels of biomarkers (CD4+/- and CD8+/- ) before and after vaccination with and without ALA/SFC administration.
Total antibody level and neutralizing antibody level
Exploratory Endpoints:
Measurement of total IgA, IgM and IgG antibodies against SARS-CoV 2.
Measurement of neutralizing antibodies against SARS-CoV-2.
Safety:
The following safety endpoints will be assessed:
Clinical laboratory assessments (hepatic function,)
All reports of AEs and SAEs Grade III and IV (CTC) with reasonable possibility of causal relationship to 5-ALA-Phosphate + SFC
Efficacy:
Efficacy will be assessing the immune system related T-helper cells and antibodies after SARS-CoV-2 vaccination for each subject.
From day 0 onwards, all subjects keep a subject diary, which they fill out daily in order to record the dosage with the study treatment. Patients must meet the testing requirements on the day of the first vaccination (Day 0) and on the Day of the second vaccination and on Day 28 and on Follow-up visit.
The food supplement 5-Aminolevulinic acid phosphate and Sodium ferrous citrate (5-ALA-Phosphate + SFC) will be administered orally daily for 4 weeks at the following TOTAL daily doses:
Subjects in the vaccination + ALA/SFC arm (Arm 1) will receive:
β’ 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) total daily dose for 28 days
Heme is critical for appropriate oxygen binding and delivery to remote site and without the heme contained within the hemoglobin tetramer, multicellular organisms would be unable to survive. Furthermore HO-1 degrades heme into biliverdin, carbon monoxide (CO), and iron, and biliverdin is immediately reduced and turned into bilirubin by biliverdin reductase. Biliverdin/bilirubin and CO both have anti-oxidative functions and they regulate important biological processes like inflammation, apoptosis, cell proliferation, fibrosis, and angiogenesis. Therefore, HO-1 is deemed to be a promising drug target (Ryter 2006). HO-1 is a major anti-inflammatory enzyme and a key regulator that induces immune tolerance.
5-ALA-Phosphate + SFC increases heme metabolism and HO-1 via enhancement of porphyrin biology and utilizes the HO-1 for endothelial pacification strategy. Nishio reported 2014 that 5-aminolevulinic acid, a precursor of heme, in combination with divalent iron (SFC) is also able to induce HO-1 in vitro (Nishio 2014). This was attributed to the upregulation of heme synthesis and that 5-ALA+SFC transiently increased the intracellular heme amount through the phosphorylation of ERK / p38 and the nuclear translocation of a transcription factor Nrf2, as well as the depletion of a repressor protein BACH1 binding to the promoter site of HO-1. Similarly, Nakaso et al., 2003, Nishio et al., 2014, Ogawa et al., 2001, Saito et al., 2017 found that hemin administration promoted Nrf2 nuclear translocation and BACH1 dissociation leading to HO-1 induction.
Ito found in 2018 that the combination of 5-ALA 600 mg and sodium ferrous citrate (SFC) 942 mg upregulated HO-1 in PBMC at 8 h after administration while sole administration of 5-ALA or SFC was unable to induce HO-1. HO-1 in blood myeloid and plasmacytoid dendritic cells was also upregulated by the combination of 5-ALA + SFC.
In summary the versatility of the administration of 5-ALA plus iron citrate (SFC) enables the body to counteract the inflammatory reactions that the virus induces in the endothelial system and multiple organs in the event of a virus attack by increasing the formation of HO-1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-COV 2, Covid19
Keywords
5-ALAPhosphate + SFC, COVID-19 Vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccinated with 1st dose of COVID-19 Vaccine & treated with 5-ALA Phosphate/SFC
Arm Type
Experimental
Arm Description
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
Arm Title
Vaccinated with 1st dose of COVID-19 Vaccine
Arm Type
No Intervention
Arm Description
100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only (Control)
Intervention Type
Dietary Supplement
Intervention Name(s)
5-ALA-Phosphate + SFC (5-ALA+SFC)
Intervention Description
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).
Primary Outcome Measure Information:
Title
To determine the safety of a 4 week daily oral administration of 5-ALA + SFC in subject vaccinated with COVID-19 Vaccine
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of 5-ALA + SFC in activating the immune system in subject vaccinated with COVID-19 Vaccine
Description
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
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Measurement of total IgA, IgM and IgG antibodies against SARS-CoV 2
Description
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
Time Frame
28 days
Title
Clinical laboratory assessments (hepatic function)
Description
Monitoring of the liver enzymes before and during the study
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
Aged β₯ 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdulla Darwish, Dr
Organizational Affiliation
Bahrain Defense Force Royal Medical Services, Military Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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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
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