Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients

Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14

Clinical status derives from death, hospital discharge, and 9-Point Ordinal Scale as follows: score of "8" use for all days on or after the date of death; score of "0" use for all days on or after discharged alive date; last available assessment for missing value. The scale is as follows: 8. Death; 7. Hospitalized, on invasive mechanical ventilation with vasopressor or Extracorporeal Membrane Oxygenation; 6. Hospitalized, on invasive mechanical ventilation; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 3. Hospitalized, not requiring supplemental oxygen - requires ongoing medical care (coronavirus (COVID-19) related or otherwise; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 1. Not hospitalized, no limitation on activities; 0. No clinical or virological evidence of infection

Time frame: Day 14

Time to an improvement of one category from admission on 9-Point Ordinal Scale

Time to reach an improvement of one category from admission on 9-Point Ordinal Scale. The scale is as follows: 8. Death; 7. Hospitalized, on invasive mechanical ventilation with vasopressor or Extracorporeal Membrane Oxygenation; 6. Hospitalized, on invasive mechanical ventilation; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 3. Hospitalized, not requiring supplemental oxygen - requires ongoing medical care (coronavirus (COVID-19) related or otherwise; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 1. Not hospitalized, no limitation on activities; 0. No clinical or virological evidence of infection

Time frame: Day 1 through Day 29

Time to an improvement of two categories from admission on 9-Point Ordinal Scale

Time to reach an improvement of two categories from admission on 9-Point Ordinal Scale. The scale is as follows: 8. Death; 7. Hospitalized, on invasive mechanical ventilation with vasopressor or Extracorporeal Membrane Oxygenation; 6. Hospitalized, on invasive mechanical ventilation; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 3. Hospitalized, not requiring supplemental oxygen - requires ongoing medical care (coronavirus (COVID-19) related or otherwise; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 1. Not hospitalized, no limitation on activities; 0. No clinical or virological evidence of infection

Time frame: Day 1 through Day 29

Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day at days 3, 5, 8, 11,14 and 29

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8. Death; 7. Hospitalized, on invasive mechanical ventilation with vasopressor or Extracorporeal Membrane Oxygenation; 6. Hospitalized, on invasive mechanical ventilation; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 3. Hospitalized, not requiring supplemental oxygen - requires ongoing medical care (coronavirus (COVID-19) related or otherwise; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 1. Not hospitalized, no limitation on activities; 0. No clinical or virological evidence of infection

Time frame: Days 3, 5, 8, 11,14 and 29

Mean change in the ranking on 9-Point Ordinal Scale from baseline to days 3, 5, 8, 11, 14 and 29

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8. Death; 7. Hospitalized, on invasive mechanical ventilation with vasopressor or Extracorporeal Membrane Oxygenation; 6. Hospitalized, on invasive mechanical ventilation; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring low flow supplemental oxygen; 3. Hospitalized, not requiring supplemental oxygen - requires ongoing medical care (coronavirus (COVID-19) related or otherwise; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 1. Not hospitalized, no limitation on activities; 0. No clinical or virological evidence of infection

Time frame: Days 3, 5, 8, 11, 14 and 29

Duration of conventional oxygen therapy Use

Duration of conventional oxygen therapy use measured in days among participants who were on conventional oxygen therapy use at baseline

Time frame: Day 1 through Day 29

Duration of new conventional oxygen therapy use

Duration of new conventional oxygen therapy use measured in days among participants who were not on conventional oxygen therapy use at baseline

Time frame: Day 1 through Day 29

Duration of Non-invasive Ventilation or High Flow Oxygen Use

Duration of non-invasive ventilation or high flow oxygen use measured in days among participants who were on non-invasive ventilation or high-flow oxygen use at baseline

Time frame: Day 1 through Day 29

Duration of New Non-invasive Ventilation or High Flow Oxygen Use

Duration of new non-invasive ventilation or high flow oxygen use measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline

Time frame: Day 1 through Day 29

Duration of Mechanical Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use

Duration of Mechanical Ventilator or ECMO Use in days among all participants to whom it will be administrated

Time frame: Day 1 through Day 29

Percentage of Participants Requiring New Oxygen Use

The percentage of participants requiring new oxygen determined as the percentage of participants not requiring oxygen at baseline

Time frame: Day 1 through Day 29

Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use

New non-invasive ventilation or high-flow oxygen use determined as the percentage of subjects not on non-invasive ventilation or high-flow oxygen at baseline.

Time frame: Day 1 through Day 29

Percentage of Participants Requiring Ventilator or ECMO Use

The percentage of participants requiring Ventilator or ECMO Use

Time frame: Day 1 through Day 29

Incidents of post-COVID-19 related symptoms at Day 29

Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form

Time frame: Day 29

Incidents of post-COVID-19 related symptoms at Day 60

Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form

Time frame: Day 60

Percentage of participants with post-COVID-19 related symptoms at Day 29

Percentage of participants with presents post-COVID-19 related symptoms

Time frame: Day 29

Percentage of participants with post-COVID-19 related symptoms at Day 60

Percentage of participants with presents post-COVID-19 related symptoms

Time frame: Day 60

Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)

Grade 3 AEs are defined as events interrupting daily living activities, or significantly affecting clinical status, or requiring intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as potentially life threatening.

Time frame: Day 1 through Day 29

Percentage of Participants Reporting Serious Adverse Events (SAEs)

An SAE is defined as an AE or a suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.

Time frame: Day 1 through Day 29

Percentage of Participants Discontinued or Temporarily Suspended From Investigational dietary supplements

Participants may have discontinued from investigational dietary supplements due to product intolerability, applied mechanical ventilation, swallowing impairment, or death. The discontinuation or temporary suspension intake of studied supplements for any reason will be collected.

Time frame: Day 1 through Day 14

Change From Baseline in Alanine Transaminase (ALT)

To evaluate ALT, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in Aspartate Transaminase (AST)

To evaluate AST, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in Total Bilirubin

To evaluate Total Bilirubin, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in Creatinine

To evaluate serum Creatinine, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in Glucose

To evaluate serum Glucose, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in Hemoglobin

To evaluate Hemoglobin, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in Platelets

To evaluate Platelets, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in White Blood Cell Count (WBC)

To evaluate WBC, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29

Change From Baseline in Lymphocytes

To evaluate Lymphocytes, blood will be collected at Days 1, 7, and 14 while participants are inpatient, and at Day 29, with the Day 1 assessment serving as the baseline. Participants who will be discharged will have blood collected if infection control measures allow in-person visits after discharge.

Time frame: Days 1, 7, 14 and 29