Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC in Subjects With COVID-19
Condition: SARS-CoV 2; COVID-19
MeSH terms: COVID-19
Study type: Interventional

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.
    

Intervention name(s): 5-ALA-Phosphate + SFC (5-ALA + SFC)
Intervention type(s): Dietary Supplement
Intervention description(s): 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
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: 5-ALAPhosphate + SFC; COVID-19