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

NCT04854876 | Withdrawn DMC

• 1 other identifier: BDF/R&REC/2021-566
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

SARS-COV 2; Covid19

Keywords

5-ALAPhosphate + SFC; COVID-19 Vaccination

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Secondary Outcomes (1)

• To evaluate the efficacy of 5-ALA + SFC in activating the immune system in subject vaccinated with COVID-19 Vaccine

  28 days

Other Outcomes (2)

• Measurement of total IgA, IgM and IgG antibodies against SARS-CoV 2

  28 days

• Clinical laboratory assessments (hepatic function)

  28 days

Study Arms (2)

Vaccinated with 1st dose of COVID-19 Vaccine & treated with 5-ALA Phosphate/SFC

EXPERIMENTAL

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)

Vaccinated with 1st dose of COVID-19 Vaccine

NO INTERVENTION

100 subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only (Control)

Interventions

5-ALA-Phosphate + SFC (5-ALA+SFC) DIETARY_SUPPLEMENT

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).

Vaccinated with 1st dose of COVID-19 Vaccine & treated with 5-ALA Phosphate/SFC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons in Ireland - Medical University of Bahrain: lead
• Bahrain Defence Force Hospital: collaborator

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MeSH Terms

Conditions

COVID-19

Interventions

Sodium Glutamate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glutamic Acid; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Abdulla Darwish, Dr

  Bahrain Defense Force Royal Medical Services, Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 22, 2021
• Study Start: August 15, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09