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Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC in Subjects With COVID-19

Primary Purpose

SARS-CoV 2, COVID-19

Status
Completed
Phase
Not Applicable
Locations
Bahrain
Study Type
Interventional
Intervention
5-ALA-Phosphate + SFC (5-ALA + SFC)
Sponsored by
Royal College of Surgeons in Ireland - Medical University of Bahrain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV 2 focused on measuring 5-ALAPhosphate + SFC, COVID-19

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
  2. Aged ≥ 21 to 70 years
  3. Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test before beginning study dose regime
  4. qSOFA ≥ 1
  5. Currently hospitalized

  6. 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).

  7. Radiographic evidence (chest X-ray or chest CT scan) of pulmonary infiltrates
  8. Able to swallow 5 capsules of study product at dosing time points.

Exclusion Criteria:

  1. Subject has critical symptoms of COVID19 infection as defined as: high-flow oxygen therapy (>15 l/min delivered by nasal cannula or mask) or invasive mechanical ventilation signifying respiratory failure, septic shock, and/or multiple organ dysfunction ventilation at screening.
  2. Subject is nourished via a nasogastric tube
  3. Subject has acute or chronic type(s) of porphyria or a family history of porphyria
  4. Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral administration (except for photosensitivity)
  5. Pregnant or nursing women
  6. Males and females of reproductive potential who have not agreed to use an
  7. adequate method of contraception during the study For females, adequate birth control methods will be defined as: hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam For females, menopause is defined as one year without menses; if in question, a folliclestimulating hormone of >40 U/ml must be documented. Hysterectomy, bilateral oophorectomy,or bilateral tubal ligation must be documented, as applicable
  8. Subjects who are unable or unwilling to comply with requirements of the clinical trial
  9. Participation in any other clinical trial of an experimental treatment for COVID-19
  10. Evidence of multiorgan failure
  11. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  12. Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976}
  13. Any other reason that makes the subject unsuitable in the Investigator's opinion

Sites / Locations

  • Bahrain Defense Force Royal Medical Services, Military Hospital
  • Salmaniya Medical Complex

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Moderate group and Severe Group

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Overall survival
To describe time until death from any cause
Results of investigator´s assessment of patient´s oxygen therapy
To describe patient´s blood oxygenation
Results of mechanical ventilation settings
To describe mechanical ventilation settings course during study.
Results of duration of ventilation
To describe duration of patient´s ventilation
The time to resolution of patient´s symptoms
To describe patient´s specific symptoms course during study.
Results of patient´s oxygen saturation (respiratory parameters)
To describe patient´s oxygen saturation course during study.
Length of hospitalization
To describe duration of hospitalization in the patient groups.
The total time in ICU
To describe duration of residence in ICU in the patient groups.
Results of investigator´s assessment of patient´s condition using (q)SOFA score
To describe patient´s (q)SOFA score course during study.
Results of patient´s PT parameter
To describe patient´s coagulation function course during study which by evaluating the PT value.
Results of patient´s D-Dimer parameter
To describe patient´s coagulation function course during study which by evaluating the D-Dimer value.
Results of patient´s PTT parameter
To describe patient´s coagulation function course during study which by evaluating the PTT value.
Results of patient´s SARS-CoV-2 viral load status (efficacy)
To describe patient's SARS-CoV-2 viral load course during study.
Results of patient´s Procalcitonin level.
To describe infection parameter course of each patient during study by evaluating the Procalcitonin value.
Results of patient´s IL-6 level
To describe infection parameter course of each patient during study by evaluating the IL-6 value.
Results of patient´s Serum Ferritin level
To describe infection parameter course of each patient during study by evaluating the Serum ferritin value.
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.
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.
Results of patient´s Bilirubin level.
To describe infection parameter course of each patient during study by evaluating the Bilirubin value.
Results on patient´s Leucocytes
To describe laboratory assessments course during study by evaluating Leucocytes value
Results on patient´s Neutrophils
To describe laboratory assessments course during study by evaluating Neutrophils value
Results on patient´s Lymphocyte
To describe laboratory assessments course during study by evaluating Lymphocyte value
Results on patient´s Platelets
To describe laboratory assessments course during study by evaluating Platelets value
Results on patient´s Hemoglobin
To describe laboratory assessments course during study by evaluating Hemoglobin value
Results on patient´s Albumin
To describe laboratory assessments course during study by evaluating Albumin value
Results on patient´s AST
To describe laboratory assessments course during study by evaluating AST value
Results on patient´s ALT
To describe laboratory assessments course during study by evaluating ALT value
Results on patient´s Total bilirubin
To describe laboratory assessments course during study by evaluating Total bilirubin value
Results on patient´s Blood urea nitrogen
To describe laboratory assessments course during study by evaluating Blood urea nitrogen value
Results on patient´s Serum creatinine
To describe laboratory assessments course during study by evaluating Serum creatinine value
Results on patient´s Creatinine kinase
To describe laboratory assessments course during study by evaluating Creatinine kinase value
Results on patient´s LDH
To describe laboratory assessments course during study by evaluating LDH value
Results on patient´s Myoglobin glucose
To describe laboratory assessments course during study by evaluating Myoglobin glucose value
Results on patient´s aPTT
To describe laboratory assessments course during study by evaluating aPTT value
Results on patient´s urine
To describe laboratory assessments course during study by evaluating urinalysis (urine test strip)
Results on hepatic function
To describe laboratory assessments course during study by evaluating hepatic function
Results on patient´s renal function
To describe laboratory assessments course during study by evaluating renal function
Results on patient´s iron parameters
To describe laboratory assessments course during study by evaluating iron parameters
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.
Results on patient´s Co-infections
To describe patient's Co-infections course during study.
Results on patient´s Care Level
To describe patient´s care level course during study.
Results on patient´s Mean arterial pressure(MAP)
To describe patient´s vital signs course during study by evaluating Mean arterial pressure(MAP)
Results on patient´s heart rate (HR)
To describe patient´s vital signs course during study by evaluating heart rate (HR)
Results on patient´s respiratory rate (RR)
To describe patient´s vital signs course during study by evaluating respiratory rate (RR)
Results on patient´s 12-lead ECG
To describe patient´s 12-lead ECG result course during study.
Organ damage
To describe patient´s organ damage status during the study

Full Information

First Posted
August 16, 2020
Last Updated
February 8, 2022
Sponsor
Royal College of Surgeons in Ireland - Medical University of Bahrain
Collaborators
Bahrain Defence Force Hospital, Salmaniya Medical Complex
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1. Study Identification

Unique Protocol Identification Number
NCT04542850
Brief Title
Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC in Subjects With COVID-19
Official Title
An Open-Label, Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-Aminolevulinic Acid Phosphate and Sodium Ferrous Citrate (5-ALA-Phosphate + SFC) in Subjects With SARS-CoV-2 Infection (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
October 28, 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, Salmaniya Medical Complex

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, 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV 2, COVID-19
Keywords
5-ALAPhosphate + SFC, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open label pilot study involving 40 patients with COVID-19 disease. Patients that are hospitalized due to confirmed SARS-CoV-2 infection will be assigned to two groups according o their severity grade (moderate or severe).
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate group and Severe Group
Arm Type
Other
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
5-ALA-Phosphate + SFC (5-ALA + SFC)
Intervention Description
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
Primary Outcome Measure Information:
Title
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).
Description
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
Secondary Outcome Measure Information:
Title
Sum COVID-19 Modified Ordinal Scale for Clinical Improvement maximum daily score over 28 days of dosing for Moderate group and for Severe group
Description
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
Title
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
Description
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
Title
Patient and subgroup profile of COVID-19 Modified Ordinal Scale for Clinical Improvement score vs. days hospitalized
Description
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
Title
Overall survival
Description
To describe time until death from any cause
Time Frame
day 14 and day 28
Title
Results of investigator´s assessment of patient´s oxygen therapy
Description
To describe patient´s blood oxygenation
Time Frame
28 days
Title
Results of mechanical ventilation settings
Description
To describe mechanical ventilation settings course during study.
Time Frame
28 days
Title
Results of duration of ventilation
Description
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
Title
The time to resolution of patient´s symptoms
Description
To describe patient´s specific symptoms course during study.
Time Frame
28 days
Title
Results of patient´s oxygen saturation (respiratory parameters)
Description
To describe patient´s oxygen saturation course during study.
Time Frame
28 days
Title
Length of hospitalization
Description
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
Title
The total time in ICU
Description
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
Title
Results of investigator´s assessment of patient´s condition using (q)SOFA score
Description
To describe patient´s (q)SOFA score course during study.
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results of patient´s PT parameter
Description
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
Title
Results of patient´s D-Dimer parameter
Description
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
Title
Results of patient´s PTT parameter
Description
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
Title
Results of patient´s SARS-CoV-2 viral load status (efficacy)
Description
To describe patient's SARS-CoV-2 viral load course during study.
Time Frame
day 7, 14 and 28
Title
Results of patient´s Procalcitonin level.
Description
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
Title
Results of patient´s IL-6 level
Description
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
Title
Results of patient´s Serum Ferritin level
Description
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
Title
Results of patient´s C-Reactive protein (CRP) level
Description
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
Title
Results of patient´s T helper cells (CD4/CD8) level.
Description
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
Title
Results of patient´s Bilirubin level.
Description
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
Title
Results on patient´s Leucocytes
Description
To describe laboratory assessments course during study by evaluating Leucocytes value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Neutrophils
Description
To describe laboratory assessments course during study by evaluating Neutrophils value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Lymphocyte
Description
To describe laboratory assessments course during study by evaluating Lymphocyte value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Platelets
Description
To describe laboratory assessments course during study by evaluating Platelets value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Hemoglobin
Description
To describe laboratory assessments course during study by evaluating Hemoglobin value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Albumin
Description
To describe laboratory assessments course during study by evaluating Albumin value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s AST
Description
To describe laboratory assessments course during study by evaluating AST value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s ALT
Description
To describe laboratory assessments course during study by evaluating ALT value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Total bilirubin
Description
To describe laboratory assessments course during study by evaluating Total bilirubin value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Blood urea nitrogen
Description
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
Title
Results on patient´s Serum creatinine
Description
To describe laboratory assessments course during study by evaluating Serum creatinine value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Creatinine kinase
Description
To describe laboratory assessments course during study by evaluating Creatinine kinase value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s LDH
Description
To describe laboratory assessments course during study by evaluating LDH value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s Myoglobin glucose
Description
To describe laboratory assessments course during study by evaluating Myoglobin glucose value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s aPTT
Description
To describe laboratory assessments course during study by evaluating aPTT value
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s urine
Description
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
Title
Results on hepatic function
Description
To describe laboratory assessments course during study by evaluating hepatic function
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s renal function
Description
To describe laboratory assessments course during study by evaluating renal function
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s iron parameters
Description
To describe laboratory assessments course during study by evaluating iron parameters
Time Frame
day 0, 2, 3, 5, 7, 10, 14, 21, 28
Title
Results on patient´s physical examination
Description
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
Title
Results on patient´s Co-infections
Description
To describe patient's Co-infections course during study.
Time Frame
28 days
Title
Results on patient´s Care Level
Description
To describe patient´s care level course during study.
Time Frame
28 days
Title
Results on patient´s Mean arterial pressure(MAP)
Description
To describe patient´s vital signs course during study by evaluating Mean arterial pressure(MAP)
Time Frame
28 days
Title
Results on patient´s heart rate (HR)
Description
To describe patient´s vital signs course during study by evaluating heart rate (HR)
Time Frame
28 days
Title
Results on patient´s respiratory rate (RR)
Description
To describe patient´s vital signs course during study by evaluating respiratory rate (RR)
Time Frame
28 days
Title
Results on patient´s 12-lead ECG
Description
To describe patient´s 12-lead ECG result course during study.
Time Frame
day 0, 7, 14 and 28
Title
Organ damage
Description
To describe patient´s organ damage status during the study
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide written informed consent, or with a legal representative who can provide informed consent Aged ≥ 21 to 70 years Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test before beginning study dose regime qSOFA ≥ 1 Currently hospitalized 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). Radiographic evidence (chest X-ray or chest CT scan) of pulmonary infiltrates Able to swallow 5 capsules of study product at dosing time points. Exclusion Criteria: Subject has critical symptoms of COVID19 infection as defined as: high-flow oxygen therapy (>15 l/min delivered by nasal cannula or mask) or invasive mechanical ventilation signifying respiratory failure, septic shock, and/or multiple organ dysfunction ventilation at screening. Subject is nourished via a nasogastric tube 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 For females, adequate birth control methods will be defined as: hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam For males, adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam For females, menopause is defined as one year without menses; if in question, a folliclestimulating hormone of >40 U/ml must be documented. Hysterectomy, bilateral oophorectomy,or bilateral tubal ligation must be documented, as applicable 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 Evidence of multiorgan failure Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} Any other reason that makes the subject unsuitable in the Investigator's opinion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Darwish, Dr
Organizational Affiliation
Bahrain Defense Force Royal Medical Services, Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahrain Defense Force Royal Medical Services, Military Hospital
City
Manama
Country
Bahrain
Facility Name
Salmaniya Medical Complex
City
Manama
Country
Bahrain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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).
IPD Sharing 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.
Citations:
PubMed Identifier
30577437
Citation
El Kalamouni C, Frumence E, Bos S, Turpin J, Nativel B, Harrabi W, Wilkinson DA, Meilhac O, Gadea G, Despres P, Krejbich-Trotot P, Viranaicken W. Subversion of the Heme Oxygenase-1 Antiviral Activity by Zika Virus. Viruses. 2018 Dec 20;11(1):2. doi: 10.3390/v11010002.
Results Reference
background
PubMed Identifier
1244564
Citation
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
Results Reference
background
PubMed Identifier
16547262
Citation
Devadas K, Dhawan S. Hemin activation ameliorates HIV-1 infection via heme oxygenase-1 induction. J Immunol. 2006 Apr 1;176(7):4252-7. doi: 10.4049/jimmunol.176.7.4252.
Results Reference
background
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