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Trial - NCT04854876


Column Value
Trial registration number NCT04854876
Full text link
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04854876

First author
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Abdulla Darwish, Dr

Contact
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

abdulla.darwish@bdfmedical.org

Registration date
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-04-22

Recruitment status
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

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
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Royal College of Surgeons in Ireland - Medical University of Bahrain

Inclusion age min
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

21

Inclusion age max
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Sept. 23, 2021, 6:30 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

To determine the safety of a 4 week daily oral administration of 5-ALA + SFC in subject vaccinated with COVID-19 Vaccine

Notes
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : April 24, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only\u00a0", "treatment_id": 1703, "treatment_name": "5-ala/sfc+sars-cov-2 vaccine", "treatment_type": "Nutrition+inactivated virus", "pharmacological_treatment": "Non pharmacological treatment+vaccine"}, {"arm_notes": "subjects that were vaccinated with the first dose of a COVID-19 Vaccine (any brand approved in Bahrain is permitted) only\u00a0", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]