An interventional study of 5-ALA-Phosphate + SFC (5-ALA + SFC) in SARS-CoV 2 and COVID-19, sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain. Completed at 2 sites in Bahrain. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain · Not applicable, Interventional, and Treatment
This is an open-label, interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate + SFC in subjects with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19) involving 40 subjects.
The primary objective is to evaluate the safety of 4-week oral administration of 5-ALAPhosphate + SFC. This study is expected to last for 4 weeks and will include follow-up until day 28 in the hospital or in an outpatient setting if the subjects are discharged earlier.
This is an open-label, interventional exploratory study to evaluate the safety and efficacy of 5-ALA-Phosphate + SFC in subjects with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19).
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.
The primary endpoints of this study is- all treatment emergent AEs and SAEs Grade III and IV (CTC) with reasonable possibility of causal relationship to 5-ALA-Phosphate + SFC. 40 subjects with symptoms requiring hospitalization will be enrolled in thestudy, with 20 subjects enrolled in each group below:
Group 1: 20 Moderately ill hospitalized subjects not requiring assisted ventilation Group 2: 20 Severely ill hospitalized subjects requiring assisted ventilation
The duration of this clinical study will be 4 weeks, and follow-up will be performed until Day 28 in hospital, or in an outpatient setting if subjects improve and are discharged home or to alternative care facility.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 15 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Royal College of Surgeons in Ireland - Medical University of Bahrain is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Moderate COVID-19 patients should meet any of the following criteria:
evidence of lower respiratory disease by clinical assessment (qSOFA ≥ 1or imaging) and saturation of oxygen (SpO2) ≥94% on room air at sea level.
Severe COVID-19 patients should meet any of the following criteria: a respiratory frequency >30 breaths per minute, SpO2 \<94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mmHg, and lung infiltrates >50% (if possible to measure). In exceptional cases the investigator can decide due to certain signs and symptoms to assign a moderate patient to the severe group although not all criteria mentioned before are fulfilled (to be documented with explanation).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moderate group and Severe group - . Both groups will be administered 5-aminolevulinic acid (5-ALA) is a natural delta amino acid widely present in nature that can be found in common food. 5-ALA combined with sodium ferrous citrate (SFC) produces the nutritional dietary supplement 5-ALA-Phosphate + SFC (5-ALA + SFC).
Dietary Supplement: 5-ALA-Phosphate + SFC (5-ALA + SFC)
Moderately ill hospitalized patients will receive: 250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) two times daily (resulting in 500 mg 5-ALA-Phosphate and 286.8 mg SFC (30.4 mg as Fe) daily) for 7 days, then 250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) once daily for 21 days Severely ill hospitalized patients will receive: 250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) three times daily (resulting in 750 mg 5-ALA-Phosphate and 430.2 mg SFC (45.6 mg as Fe) daily) for 7 days, then 250 mg 5-ALA-Phosphate and 143.4 mg SFC (15.2 mg as Fe) once daily for 21 days
The incidence of treatment emergent Adverse Events (safety and tolerability) of 5-ALA-Phospate + SFC in patients with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19).
To describe the incidence of treatment-emergent Adverse Events (TEAEs) of CTC Grades III and IV within four weeks following base line dose.
Time frame: 28 days
Sum COVID-19 Modified Ordinal Scale for Clinical Improvement maximum daily score over 28 days of dosing for Moderate group and for Severe group
To describe patient's condition in Moderate and Severe group using average, median, minimum and maximum in COVID-19 Modified Ordinal Scale for Clinical Improvement score.
Time frame: 28 days
Rate of change in COVID-19 Modified Ordinal Scale for Clinical Improvement maximum daily score over 28 days of dosing for individual subjects in Moderate group and in Severe group
To describe patient´s condition in Moderate and Severe Group using rate of change in COVID-19 Modified Ordinal Scale for Clinical Improvement score.
Time frame: 28 days
Patient and subgroup profile of COVID-19 Modified Ordinal Scale for Clinical Improvement score vs. days hospitalized
To describe patient´s condition in Moderate and Severe Group using patient and subgroup profile of COVID-19 Modified Ordinal Scale for Clinical Improvement score vs. days hospitalized.
Time frame: 28 days
Overall survival
To describe time until death from any cause
Time frame: day 14 and day 28
Results of investigator´s assessment of patient´s oxygen therapy
To describe patient´s blood oxygenation
Time frame: 28 days
Results of mechanical ventilation settings
To describe mechanical ventilation settings course during study.
Time frame: 28 days
Results of duration of ventilation
To describe duration of patient´s ventilation
Time frame: from date of enrolment until the extubation or until last 5-ALA- Phosphate -SFC administration on day 28
The time to resolution of patient´s symptoms
To describe patient´s specific symptoms course during study.
Time frame: 28 days
Results of patient´s oxygen saturation (respiratory parameters)
To describe patient´s oxygen saturation course during study.
Time frame: 28 days
Length of hospitalization
To describe duration of hospitalization in the patient groups.
Time frame: From date of enrolment until last 5-ALA- Phosphate -SFC administration at day 28
The total time in ICU
To describe duration of residence in ICU in the patient groups.
Time frame: From date of enrolment until last 5-ALA- Phosphate -SFC administration at day 28
Results of investigator´s assessment of patient´s condition using (q)SOFA score
To describe patient´s (q)SOFA score course during study.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s PT parameter
To describe patient´s coagulation function course during study which by evaluating the PT value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s D-Dimer parameter
To describe patient´s coagulation function course during study which by evaluating the D-Dimer value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s PTT parameter
To describe patient´s coagulation function course during study which by evaluating the PTT value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s SARS-CoV-2 viral load status (efficacy)
To describe patient's SARS-CoV-2 viral load course during study.
Time frame: day 7, 14 and 28
Results of patient´s Procalcitonin level.
To describe infection parameter course of each patient during study by evaluating the Procalcitonin value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s IL-6 level
To describe infection parameter course of each patient during study by evaluating the IL-6 value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s Serum Ferritin level
To describe infection parameter course of each patient during study by evaluating the Serum ferritin value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s C-Reactive protein (CRP) level
To describe infection parameter course of each patient during study by evaluating the C-Reactive protein (CRP) value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s T helper cells (CD4/CD8) level.
To describe infection parameter course of each patient during study by evaluating the T helper cells (CD4/CD8) value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results of patient´s Bilirubin level.
To describe infection parameter course of each patient during study by evaluating the Bilirubin value.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Leucocytes
To describe laboratory assessments course during study by evaluating Leucocytes value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Neutrophils
To describe laboratory assessments course during study by evaluating Neutrophils value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Lymphocyte
To describe laboratory assessments course during study by evaluating Lymphocyte value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Platelets
To describe laboratory assessments course during study by evaluating Platelets value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Hemoglobin
To describe laboratory assessments course during study by evaluating Hemoglobin value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Albumin
To describe laboratory assessments course during study by evaluating Albumin value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s AST
To describe laboratory assessments course during study by evaluating AST value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s ALT
To describe laboratory assessments course during study by evaluating ALT value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Total bilirubin
To describe laboratory assessments course during study by evaluating Total bilirubin value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Blood urea nitrogen
To describe laboratory assessments course during study by evaluating Blood urea nitrogen value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Serum creatinine
To describe laboratory assessments course during study by evaluating Serum creatinine value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Creatinine kinase
To describe laboratory assessments course during study by evaluating Creatinine kinase value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s LDH
To describe laboratory assessments course during study by evaluating LDH value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Myoglobin glucose
To describe laboratory assessments course during study by evaluating Myoglobin glucose value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s aPTT
To describe laboratory assessments course during study by evaluating aPTT value
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s urine
To describe laboratory assessments course during study by evaluating urinalysis (urine test strip)
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on hepatic function
To describe laboratory assessments course during study by evaluating hepatic function
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s renal function
To describe laboratory assessments course during study by evaluating renal function
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s iron parameters
To describe laboratory assessments course during study by evaluating iron parameters
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s physical examination
To describe patient´s conditions course during study using physical examination which include General Appearance, ENT, Respiratory, Cardiovascular, Musculoskeletal, Skin and Neurological.
Time frame: day 0, 2, 3, 5, 7, 10, 14, 21, 28
Results on patient´s Co-infections
To describe patient's Co-infections course during study.
Time frame: 28 days
Results on patient´s Care Level
To describe patient´s care level course during study.
Time frame: 28 days
Results on patient´s Mean arterial pressure(MAP)
To describe patient´s vital signs course during study by evaluating Mean arterial pressure(MAP)
Time frame: 28 days
Results on patient´s heart rate (HR)
To describe patient´s vital signs course during study by evaluating heart rate (HR)
Time frame: 28 days
Results on patient´s respiratory rate (RR)
To describe patient´s vital signs course during study by evaluating respiratory rate (RR)
Time frame: 28 days
Results on patient´s 12-lead ECG
To describe patient´s 12-lead ECG result course during study.
Time frame: day 0, 7, 14 and 28
Organ damage
To describe patient´s organ damage status during the study
Time frame: 28 days
Plan to share: Yes — Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 5 years after study completion (last patient, last study point).
Access criteria: Study documents (paper) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.
Ran from Nov 2020 to primary completion in Aug 2021, 9 months.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 9 months is close to that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Royal College of Surgeons in Ireland - Medical University of Bahrain