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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAF capsules | Experimental | MAF capsules 148 mg TID for 14 days + Standard of care |
|
| M capsules | Experimental | M capsules 148 mg TID for 14 days + Standard of care |
|
| Comparison | Active Comparator | Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAF capsules 148 mg | Dietary Supplement | enteric capsules based on enzymatically treated bovine colostrum |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time to basic clinical improvement and to recovery defined as the following |
| Day 1 through Day 29 |
| 14-day Participant Mortality | The mortality rate will be determined as the proportion of participants who died by study Day 14 | Day 1 through Day 14 |
| 29-day Participant Mortality | The mortality rate will be determined as the proportion of participants who died by study Day 29 | Day 1 through Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in C-Reactive Protein | 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 | Days 1, 7 and 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Central Hospital of Rubizhne, Infection Disease Department | Rubizhne | Luhansk Oblast | 93012 | Ukraine | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31366556 | Background | 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. | |
| 26168491 | Background | 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. |
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The data will be shared via ISARIC COVID-19 Clinical Database.
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Request for data will be indefinitely available
Reasonable request to investigators
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| M capsules 148 mg | Dietary Supplement | enteric capsules based on enzymatically treated bovine whey |
|
| Standard of care | Other | Standard of care |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | Day 1 through Day 29 |
| Percentage of Participants Requiring Ventilator or ECMO Use | The percentage of participants requiring Ventilator or ECMO Use | 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 | 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 | Day 60 |
| Percentage of participants with post-COVID-19 related symptoms at Day 29 | Percentage of participants with presents post-COVID-19 related symptoms | Day 29 |
| Percentage of participants with post-COVID-19 related symptoms at Day 60 | Percentage of participants with presents post-COVID-19 related symptoms | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Days 1, 7, 14 and 29 |
| Change From Baseline in D-Dimer | 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 | Days 1, 7 and 14 |
| Change From Baseline in Lactate Dehydrogenase | 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 | Days 1, 7 and 14 |
| Change From Baseline in Ferritin | 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 | Days 1, 7 and 14 |
| Municipal Kharkiv Regional Infectious Diseases Clinical Hospital |
| Kharkiv |
| 61000 |
| Ukraine |
| 32013346 | Background | 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. |
| 38783176 | Derived | Inui T, Kruglova O, Martynenko O, Martynenko K, Tieroshyn V, Gavrylov A, Kubo K, Yamakage H, Kutsyn B, Kubashko A, Veklych Z, Terashima Y, Mette M, Kutsyna G. Effect of degalactosylated bovine glycoprotein formulations MAF and M small es, Cyrillicapsules on lymphopenia and clinical outcomes in hospitalized COVID-19 patients: a randomized clinical trial. BMC Infect Dis. 2024 May 23;24(1):519. doi: 10.1186/s12879-024-09286-0. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |