Covid19SaiseiCovUKRNCT04762628
Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients
A study testing MAF capsules 148 mg and M capsules 148 mg in people with Covid19, run by Saisei Pharma at 2 sites in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- MAF capsules 148 mg and M capsules 148 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUkraine
- Study dates
- 27 Oct 2020to 6 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
Municipal Kharkiv Regional Infectious Diseases Clinical Hospital
Kharkiv, 61000
The Central Hospital of Rubizhne, Infection Disease Department
Rubizhne, Luhansk Oblast, 93012
About this study
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
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- MAF capsules 148 mg, M capsules 148 mg, Standard of care
- Keywords
- Covid19, Colostrum MAF, Supplements, Oxygen supply, Mortality, Clinical improvement, lymphocyte depletion prevention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAF capsules 148 mgDietary supplement
enteric capsules based on enzymatically treated bovine colostrum
M capsules 148 mgDietary supplement
enteric capsules based on enzymatically treated bovine whey
Standard of careOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| MAF capsules | Experimental | MAF capsules 148 mg TID for 14 days + Standard of care Receives: Dietary Supplement: MAF capsules 148 mg |
| M capsules | Experimental | M capsules 148 mg TID for 14 days + Standard of care Receives: Dietary Supplement: M capsules 148 mg |
| Comparison | Active comparator | Standard of care Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 1 through Day 29
Secondary outcomes (29)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1 through Day 29
Percentage of Participants Requiring Ventilator or ECMO Use
The percentage of participants requiring Ventilator or ECMO Use
Measured: 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
Measured: 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
Measured: Day 60
Percentage of participants with post-COVID-19 related symptoms at Day 29
Percentage of participants with presents post-COVID-19 related symptoms
Measured: Day 29
Percentage of participants with post-COVID-19 related symptoms at Day 60
Percentage of participants with presents post-COVID-19 related symptoms
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1, 7, 14 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start27 Oct 2020
- Primary completion5 Jul 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saisei Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762628
- Sponsor's protocol ID
- SaiseiMAF supplements COVID
- Acronym
- SaiseiCovUKR
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2021
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared via ISARIC COVID-19 Clinical Database.
Publications
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.
PubMed 31366556Uto 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.
PubMed 26168491Greilberger 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.
PubMed 32013346Inui 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.
PubMed 38783176
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04762628
- Acronym / sponsor ID
- SaiseiCovUKR / SaiseiMAF supplements COVID
- Conditions
- Covid19
- Keywords
- Covid19, Colostrum MAF, Supplements, Oxygen supply, Mortality, Clinical improvement, lymphocyte depletion prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Saisei PharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAF capsules | Experimental | Dietary Supplement: MAF capsules 148 mgMAF capsules 148 mg TID for 14 days + Standard of care |
| M capsules | Experimental | Dietary Supplement: M capsules 148 mgM capsules 148 mg TID for 14 days + Standard of care |
| Comparison | Active comparator | Other: Standard of careStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAF capsules 148 mgenteric capsules based on enzymatically treated bovine colostrum | Dietary supplement | MAF capsules |
| M capsules 148 mgenteric capsules based on enzymatically treated bovine whey | Dietary supplement | M capsules |
| Standard of careStandard of care | Other | Comparison |
Primary outcome
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
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
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
29 secondary outcomes
Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14
Time frame: Day 14
Time to an improvement of one category from admission on 9-Point Ordinal Scale
Time frame: Day 1 through Day 29
Time to an improvement of two categories from admission on 9-Point Ordinal Scale
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
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
Time frame: Days 3, 5, 8, 11, 14 and 29
Duration of conventional oxygen therapy Use
Time frame: Day 1 through Day 29
Duration of new conventional oxygen therapy use
Time frame: Day 1 through Day 29
Duration of 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
Time frame: Day 1 through Day 29
Duration of Mechanical Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Time frame: Day 1 through Day 29
Percentage of Participants Requiring New Oxygen Use
Time frame: Day 1 through Day 29
Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use
Time frame: Day 1 through Day 29
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
Time frame: Day 29
Incidents of post-COVID-19 related symptoms at Day 60
Time frame: Day 60
Percentage of participants with post-COVID-19 related symptoms at Day 29
Time frame: Day 29
Percentage of participants with post-COVID-19 related symptoms at Day 60
Time frame: Day 60
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
Time frame: Day 1 through Day 29
Percentage of Participants Reporting Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 29
Percentage of Participants Discontinued or Temporarily Suspended From Investigational dietary supplements
Time frame: Day 1 through Day 14
Change From Baseline in Alanine Transaminase (ALT)
Time frame: Days 1, 7, 14 and 29
Change From Baseline in Aspartate Transaminase (AST)
Time frame: Days 1, 7, 14 and 29
Change From Baseline in Total Bilirubin
Time frame: Days 1, 7, 14 and 29
Change From Baseline in Creatinine
Time frame: Days 1, 7, 14 and 29
Change From Baseline in Glucose
Time frame: Days 1, 7, 14 and 29
Change From Baseline in Hemoglobin
Time frame: Days 1, 7, 14 and 29
Change From Baseline in Platelets
Time frame: Days 1, 7, 14 and 29
Change From Baseline in White Blood Cell Count (WBC)
Time frame: Days 1, 7, 14 and 29
Change From Baseline in Lymphocytes
Time frame: Days 1, 7, 14 and 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 31366556Kawakatsu 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.
- Background: PubMed 26168491Uto 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.
- Background: PubMed 32013346Greilberger 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.
- Derived from this study: PubMed 38783176Inui 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.
- Individual participant dataSharing planned: Yes. The data will be shared via ISARIC COVID-19 Clinical Database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAF capsules 148 mg and M capsules 148 mg in people with Covid19, run by Saisei Pharma at 2 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to basic clinical improvement and to recovery defined as the following (time frame: Day 1 through Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04762628, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.