Back to resultsTrial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients (SaiseiCovUKR)
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
MAF capsules 148 mg
M capsules 148 mg
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid19, Colostrum MAF, Supplements, Oxygen supply, Mortality, Clinical improvement, lymphocyte depletion prevention
Eligibility Criteria
Inclusion Criteria:
- Patients found positive RT-PCR for SARS-CoV-2 in any specimen on 4 days prior to randomization, those who are hospitalized with evidence of respiratory disease during clinical assessment or imaging
- Male or non-pregnant female adult ≥18 years of age subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures
- Subject (or legally authorized representative) understands and agrees to comply with planned study procedures
- Has illness of not more than 7 days duration
- At the time of enrolment does not require immediate resuscitation or mechanical ventilation
- Respiration rate ≤ 29 per minute
- SpO2 ≤ 95% on room air
- Agrees to not participate in another clinical trial through Day 29
Exclusion Criteria:
- Pregnant or breastfeeding woman
- Known allergy to dairy products
- On corticosteroids for COVID-19 therapy at the time of screening
- Subjects who are taking corticosteroids or other immunosuppressive drugs for other medical conditions
- Concurrent malignancy requiring chemotherapy
- Known renal insufficiency with glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
- ALT or AST > 5 times the upper limit of normal
- Subjects receiving other Immune-Based Therapy for COVID-19, such as convalescent plasma, immunoglobulin products, interferons
Sites / Locations
- The Central Hospital of Rubizhne, Infection Disease Department
- Municipal Kharkiv Regional Infectious Diseases Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
MAF capsules
M capsules
Comparison
Arm Description
MAF capsules 148 mg TID for 14 days + Standard of care
M capsules 148 mg TID for 14 days + Standard of care
Standard of care
Outcomes
Primary Outcome Measures
The time to basic clinical improvement and to recovery defined as the following
Hospitalized, not requiring supplemental oxygen, requires ongoing medical care
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
Not hospitalized, limitation on activities and/or requiring home oxygen
Not hospitalized, no limitations on activities
14-day Participant Mortality
The mortality rate will be determined as the proportion of participants who died by study Day 14
29-day Participant Mortality
The mortality rate will be determined as the proportion of participants who died by study Day 29
Secondary Outcome Measures
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 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 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
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
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
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
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
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
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
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
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
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.
Percentage of Participants Requiring Ventilator or ECMO Use
The percentage of participants requiring Ventilator or ECMO Use
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
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
Percentage of participants with post-COVID-19 related symptoms at Day 29
Percentage of participants with presents post-COVID-19 related symptoms
Percentage of participants with post-COVID-19 related symptoms at Day 60
Percentage of participants with presents post-COVID-19 related symptoms
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04762628
Brief Title
Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients
Acronym
SaiseiCovUKR
Official Title
Randomized Trial to Assess the Efficacy and Safety of Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Addition to the Standard of Care (SOC) Compared SOC in the Treatment of Hospitalized With COVID-19 Patients Who Not Requiring the Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
July 5, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saisei Pharma
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
The SaiseiCovUKR clinical study is a multicentric, randomized trial study targeting patients hospitalized with COVID-19 who do not require mechanical ventilation. This study aims to provide preliminary data on the activity and safety of MAF capsules and M capsules in the target population after 14 days of dosing. MAF capsules and M capsules are dietary supplements targeting the gut's mucosal immunity to control local and systemic inflammation, limiting epithelial damage and preventing the accumulation of pathological macrophage populations at sites of SARS-CoV-2 infection.
Detailed Description
Saisei Pharma is developing biologics using an enzymatic modification of Vitamin D binding protein and other glycoproteins in biological substrates, which have been shown to increase macrophage phagocytic and antigen processing activity without promoting the proinflammatory profile of macrophages. Bovine colostrum is the substrate for MAF capsules and bovine whey for M capsules. The enteric capsules formulation of the investigational dietary supplements is targeting the gut mucosa and its associated natural anti-inflammatory macrophages profile. The SaiseiCovUKR clinical study is multicentric, randomized, open-label in hospitalized patients with moderate and severe COVID-19 to provide data on the activity and safety of MAF capsules and M capsules in the target population after 14 days of dosing. The trial will use an adaptive design based on a pre-specified criteria, using an independent external Data Monitoring Committee (DMC) to monitor safety, efficacy, and review data at appropriate intervals. The general objectives of the study are to obtain a preliminary indication of activity of MAF capsules and M capsules on shortened time to recovery and decreased mortality in the target population (600 patients, age ≥ 18 years). The study results can provide a background for further investigation of the studied dietary supplements as new drugs in COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid19, Colostrum MAF, Supplements, Oxygen supply, Mortality, Clinical improvement, lymphocyte depletion prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAF capsules
Arm Type
Experimental
Arm Description
MAF capsules 148 mg TID for 14 days + Standard of care
Arm Title
M capsules
Arm Type
Experimental
Arm Description
M capsules 148 mg TID for 14 days + Standard of care
Arm Title
Comparison
Arm Type
Active Comparator
Arm Description
Standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
MAF capsules 148 mg
Intervention Description
enteric capsules based on enzymatically treated bovine colostrum
Intervention Type
Dietary Supplement
Intervention Name(s)
M capsules 148 mg
Intervention Description
enteric capsules based on enzymatically treated bovine whey
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
The time to basic clinical improvement and to recovery defined as the following
Description
Hospitalized, not requiring supplemental oxygen, requires ongoing medical care
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
Not hospitalized, limitation on activities and/or requiring home oxygen
Not hospitalized, no limitations on activities
Time Frame
Day 1 through Day 29
Title
14-day Participant Mortality
Description
The mortality rate will be determined as the proportion of participants who died by study Day 14
Time Frame
Day 1 through Day 14
Title
29-day Participant Mortality
Description
The mortality rate will be determined as the proportion of participants who died by study Day 29
Time Frame
Day 1 through Day 29
Secondary Outcome Measure Information:
Title
Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14
Description
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
Title
Time to an improvement of one category from admission on 9-Point Ordinal Scale
Description
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
Title
Time to an improvement of two categories from admission on 9-Point Ordinal Scale
Description
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
Title
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
Description
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
Title
Mean change in the ranking on 9-Point Ordinal Scale from baseline to days 3, 5, 8, 11, 14 and 29
Description
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
Title
Duration of conventional oxygen therapy Use
Description
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
Title
Duration of new conventional oxygen therapy use
Description
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
Title
Duration of Non-invasive Ventilation or High Flow Oxygen Use
Description
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
Title
Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Description
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
Title
Duration of Mechanical Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Description
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
Title
Percentage of Participants Requiring New Oxygen Use
Description
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
Title
Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use
Description
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
Title
Percentage of Participants Requiring Ventilator or ECMO Use
Description
The percentage of participants requiring Ventilator or ECMO Use
Time Frame
Day 1 through Day 29
Title
Incidents of post-COVID-19 related symptoms at Day 29
Description
Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form
Time Frame
Day 29
Title
Incidents of post-COVID-19 related symptoms at Day 60
Description
Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form
Time Frame
Day 60
Title
Percentage of participants with post-COVID-19 related symptoms at Day 29
Description
Percentage of participants with presents post-COVID-19 related symptoms
Time Frame
Day 29
Title
Percentage of participants with post-COVID-19 related symptoms at Day 60
Description
Percentage of participants with presents post-COVID-19 related symptoms
Time Frame
Day 60
Title
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
Description
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
Title
Percentage of Participants Reporting Serious Adverse Events (SAEs)
Description
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
Title
Percentage of Participants Discontinued or Temporarily Suspended From Investigational dietary supplements
Description
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
Title
Change From Baseline in Alanine Transaminase (ALT)
Description
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
Title
Change From Baseline in Aspartate Transaminase (AST)
Description
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
Title
Change From Baseline in Total Bilirubin
Description
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
Title
Change From Baseline in Creatinine
Description
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
Title
Change From Baseline in Glucose
Description
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
Title
Change From Baseline in Hemoglobin
Description
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
Title
Change From Baseline in Platelets
Description
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
Title
Change From Baseline in White Blood Cell Count (WBC)
Description
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
Title
Change From Baseline in Lymphocytes
Description
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
Other Pre-specified Outcome Measures:
Title
Change From Baseline in C-Reactive Protein
Description
To evaluate C-Reactive Protein, blood will be collected at Days 1, 7 and 14 while participants are inpatient, 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 and 14
Title
Change From Baseline in D-Dimer
Description
To evaluate D-Dimer, blood will be collected at Days 1, 7 and 14 while participants are inpatient, 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 and 14
Title
Change From Baseline in Lactate Dehydrogenase
Description
To evaluate Lactate Dehydrogenase, blood will be collected at Days 1, 7 and 14 while participants are inpatient, 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 and 14
Title
Change From Baseline in Ferritin
Description
To evaluate Ferritin, blood will be collected at Days 1, 7 and 14 while participants are inpatient, 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 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients found to have positive RT-PCR for SARS-CoV-2 in any specimen on 4 days prior to randomization, those who are hospitalized with evidence of respiratory disease during clinical assessment or imaging
Male or non-pregnant female adult ≥18 years of age subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures
Subject (or legally authorized representative) understands and agrees to comply with planned study procedures
Has illness of not more than 7 days duration
At the time of enrolment does not require immediate resuscitation or mechanical ventilation
Respiration rate ≤ 29 per minute
SpO2 ≤ 95% on room air
Agrees to not participate in another clinical trial through Day 29
Exclusion Criteria:
Pregnant or breastfeeding women
Known allergy to dairy products
On corticosteroids for COVID-19 therapy at the time of screening
Subjects who are taking corticosteroids or other immunosuppressive drugs for other medical conditions
Concurrent malignancy requiring chemotherapy
Known renal insufficiency with glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
ALT or AST > 5 times the upper limit of normal
Subjects receiving other immune-based therapy for COVID-19, such as convalescent plasma, immunoglobulin products, interferons
Facility Information:
Facility Name
The Central Hospital of Rubizhne, Infection Disease Department
City
Rubizhne
State/Province
Luhansk Region
ZIP/Postal Code
93012
Country
Ukraine
Facility Name
Municipal Kharkiv Regional Infectious Diseases Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared via ISARIC COVID-19 Clinical Database.
IPD Sharing Time Frame
Request for data will be indefinitely available
IPD Sharing Access Criteria
Reasonable request to investigators
Citations:
PubMed Identifier
31366556
Citation
Kawakatsu K, Ishikawa M, Mashiba R, Tran NK, Akamatsu M, Nishikata T. Characteristic Morphological Changes and Rapid Actin Accumulation in Serum-MAF-treated Macrophages. Anticancer Res. 2019 Aug;39(8):4533-4537. doi: 10.21873/anticanres.13630.
Results Reference
background
PubMed Identifier
26168491
Citation
Uto Y, Kawai T, Sasaki T, Hamada K, Yamada H, Kuchiike D, Kubo K, Inui T, Mette M, Tokunaga K, Hayakawa A, Go A, Oosaki T. Degalactosylated/Desialylated Bovine Colostrum Induces Macrophage Phagocytic Activity Independently of Inflammatory Cytokine Production. Anticancer Res. 2015 Aug;35(8):4487-92.
Results Reference
background
PubMed Identifier
32013346
Citation
Greilberger J, Herwig R. Vitamin D - Deglycosylated Vitamin D Binding Protein Dimer: Positive Synergistic Effects on Recognition, Activation, Phagocytosis and Oxidative Stress on Macrophages. Clin Lab. 2020 Jan 1;66(1). doi: 10.7754/Clin.Lab.2019.191121.
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Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients
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