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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 (SaiseiCovUKR)

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ClinicalTrials.gov Identifier: NCT04762628
Recruitment Status : Active, not recruiting
First Posted : February 21, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Saisei Pharma

Brief Summary:
The SaiseiCovUKR clinical study is a multicentric, randomize trail study targeting hospitalize with COVID-19 patients who not requiring the 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 gut's mucosal immunity to control local and systemic inflammation, limiting epithelial damage and prevent the accumulation of pathological macrophage populations in sites of SARS-CoV-2 infection.

Condition or disease Intervention/treatment Phase
Covid19 Dietary Supplement: MAF capsules 148 mg Dietary Supplement: M capsules 148 mg Other: Standard of care Not Applicable

Detailed Description:
SaiSei Pharma is developing biologics using an enzymatical modification Vitamin D binging protein and other glycoproteins in biological substrates, which shown to in increase macrophages phagocytic and antigen processing activity without promoting proinflammatory profile on macrophages. Bovine colostrum is substrate MAF capsules and bovine whey for M capsules. Enteric capsules formulation of investigational dietary supplements targeting gut mucosa and its associated natural anti-inflammatory macrophages profile. The SaiseiCovUKR clinical study is multicentric, randomize, open-label in hospitalized with moderate and severe COVID-19 participants 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 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 preliminary indication of activity of MAF capsules and M capsules on shortening time to the recovery and decreasing mortality in the target population (600 patients, age ≥ 18 years). The study results can provide a background for further investigation of studied dietary supplements as new drugs in COVID-19.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : January 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MAF capsules
MAF capsules 148 mg TID for 14 days + Standard of care
Dietary Supplement: MAF capsules 148 mg
enteric capsules based on enzymatically treated bovine colostrum

Experimental: M capsules
M capsules 148 mg TID for 14 days + Standard of care
Dietary Supplement: M capsules 148 mg
enteric capsules based on enzymatically treated bovine whey

Active Comparator: Comparison
Standard of care
Other: Standard of care
Standard of care




Primary Outcome Measures :
  1. The time to basic clinical improvement and to recovery defined as the following [ Time Frame: Day 1 through Day 29 ]
    • 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

  2. 14-day Participant Mortality [ Time Frame: Day 1 through Day 14 ]
    The mortality rate will be determined as the proportion of participants who died by study Day 14

  3. 29-day Participant Mortality [ Time Frame: Day 1 through Day 29 ]
    The mortality rate will be determined as the proportion of participants who died by study Day 29


Secondary Outcome Measures :
  1. Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14 [ Time Frame: 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 evidences of infection

  2. Time to an improvement of one category from admission on 9-Point Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
    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 evidences of infection

  3. Time to an improvement of two categories from admission on 9-Point Ordinal Scale [ Time Frame: Day 1 through Day 29 ]
    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 evidences of infection

  4. 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 [ Time Frame: 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 evidences of infection

  5. Mean change in the ranking on 9-Point Ordinal Scale from baseline to days 3, 5, 8, 11, 14 and 29 [ Time Frame: 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 evidences of infection

  6. Duration of conventional oxygen therapy Use [ Time Frame: Day 1 through Day 29 ]
    Duration of conventional oxygen therapy use measures in days among participants who were on conventional oxygen therapy use at baseline

  7. Duration of new conventional oxygen therapy Use [ Time Frame: Day 1 through Day 29 ]
    Duration of new conventional oxygen therapy use measures in days among participants who were not on conventional oxygen therapy use at baseline

  8. Duration of Non-invasive Ventilation or High Flow Oxygen Use [ Time Frame: Day 1 through Day 29 ]
    Duration of non-invasive ventilation or high flow oxygen use measures in days among participants who were on non-invasive ventilation or high-flow oxygen use at baseline

  9. Duration of New Non-invasive Ventilation or High Flow Oxygen Use [ Time Frame: Day 1 through Day 29 ]
    Duration of new non-invasive ventilation or high flow oxygen use measures in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline

  10. Duration of Mechanical Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use [ Time Frame: Day 1 through Day 29 ]
    Duration of Mechanical Ventilator or ECMO Use in days among all participants to whom it will be administrated

  11. Percentage of Participants Requiring New Oxygen Use [ Time Frame: Day 1 through Day 29 ]
    The percentage of participants requiring new oxygen determine as the percentage of participants not requiring oxygen at baseline

  12. Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use [ Time Frame: Day 1 through Day 29 ]
    New non-invasive ventilation or high-flow oxygen use determines as the percentage of subjects not on non-invasive ventilation or high-flow oxygen at baseline.

  13. Percentage of Participants Requiring Ventilator or ECMO Use [ Time Frame: Day 1 through Day 29 ]
    The percentage of participants requiring Ventilator or ECMO Use

  14. Incidents of post-COVID-19 related symptoms at Day 29 [ Time Frame: Day 29 ]
    Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form

  15. Incidents of post-COVID-19 related symptoms at Day 60 [ Time Frame: Day 60 ]
    Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form

  16. Percentage of participants with post-COVID-19 related symptoms at Day 29 [ Time Frame: Day 29 ]
    Percentage of participants with presents post-COVID-19 related symptoms

  17. Percentage of participants with post-COVID-19 related symptoms at Day 60 [ Time Frame: Day 60 ]
    Percentage of participants with presents post-COVID-19 related symptoms

  18. Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) [ Time Frame: Day 1 through Day 29 ]
    Grade 3 AEs are defined as events interrupting daily living activities, or significantly affects clinical status, or require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as potentially life threatening.

  19. Percentage of Participants Reporting Serious Adverse Events (SAEs) [ Time Frame: Day 1 through Day 29 ]
    An SAE is defined as an AE or 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.

  20. Percentage of Participants Discontinued or Temporarily Suspended From Investigational dietary supplements [ Time Frame: Day 1 through Day 14 ]
    Participants may have discontinued from investigational dietary supplements due to products intolerability, applied mechanical ventilation, swallowing impairment, death. The discontinuation or temporary suspension intake of studied supplements for any reason will be collected.

  21. Change From Baseline in Alanine Transaminase (ALT) [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  22. Change From Baseline in Aspartate Transaminase (AST) [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  23. Change From Baseline in Total Bilirubin [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  24. Change From Baseline in Creatinine [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  25. Change From Baseline in Glucose [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  26. Change From Baseline in Hemoglobin [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  27. Change From Baseline in Platelets [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  28. Change From Baseline in White Blood Cell Count (WBC) [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.

  29. Change From Baseline in Lymphocytes [ Time Frame: Days 1, 7, 14 and 29 ]
    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 allowed for in-person visits after discharge.


Other Outcome Measures:
  1. Change From Baseline in C-Reactive Protein [ Time Frame: Days 1, 7 and 14 ]
    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 allowed for in-person visits after discharge

  2. Change From Baseline in D-Dimer [ Time Frame: Days 1, 7 and 14 ]
    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 allowed for in-person visits after discharge

  3. Change From Baseline in Lactate Dehydrogenase [ Time Frame: Days 1, 7 and 14 ]
    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 allowed for in-person visits after discharge

  4. Change From Baseline in Ferritin [ Time Frame: Days 1, 7 and 14 ]
    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 allowed for in-person visits after discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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
  3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures
  4. Has illness of not more than 7 days duration
  5. At the time of enrolment does not require immediate resuscitation or mechanical ventilation
  6. Respiration rate ≤ 29 per minute
  7. SpO2 ≤ 95% on room air
  8. Agrees to not participate in another clinical trial through Day 29

Exclusion Criteria:

  1. Pregnant or breastfeeding woman
  2. Known allergy to dairy products
  3. On corticosteroids for COVID-19 therapy at the time of screening
  4. Subjects who are taking corticosteroids or other immunosuppressive drugs for other medical conditions
  5. Concurrent malignancy requiring chemotherapy
  6. Known renal insufficiency with glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
  7. ALT or AST > 5 times the upper limit of normal
  8. Subjects receiving other Immune-Based Therapy for COVID-19, such as convalescent plasma, immunoglobulin products, interferons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762628


Locations
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Ukraine
The Central Hospital of Rubizhne, Infection Disease Department
Rubizhne, Luhansk Region, Ukraine, 93012
Municipal Kharkiv Regional Infectious Diseases Clinical Hospital
Kharkiv, Ukraine, 61000
Sponsors and Collaborators
Saisei Pharma
Publications:
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Responsible Party: Saisei Pharma
ClinicalTrials.gov Identifier: NCT04762628    
Other Study ID Numbers: SaiseiMAF supplements COVID
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared via ISARIC COVID-19 Clinical Database.
Time Frame: Data will be indefinitely available for requesting
Access Criteria: Reasonable request to investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saisei Pharma:
Covid19
Colostrum MAF
Supplements
Oxygen supply
Mortality
Clinical improvement
lymphocyte depletion prevention