Clinical trial NCT04762628: Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Covid19
Colostrum MAF
Supplements
Oxygen supply
Mortality
Clinical improvement
lymphocyte depletion prevention
Lead sponsor: Saisei Pharma
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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
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 women
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

Primary outcomes:
measure: The time to basic clinical improvement and to recovery defined as the following
timeFrame: Day 1 through Day 29
measure: 14-day Participant Mortality
timeFrame: Day 1 through Day 14
measure: 29-day Participant Mortality
timeFrame: Day 1 through Day 29
Secondary outcomes:
measure: Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14
timeFrame: Day 14
measure: Time to an improvement of one category from admission on 9-Point Ordinal Scale
timeFrame: Day 1 through Day 29
measure: Time to an improvement of two categories from admission on 9-Point Ordinal Scale
timeFrame: Day 1 through Day 29
measure: 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
timeFrame: Days 3, 5, 8, 11,14 and 29
measure: Mean change in the ranking on 9-Point Ordinal Scale from baseline to days 3, 5, 8, 11, 14 and 29
timeFrame: Days 3, 5, 8, 11, 14 and 29
measure: Duration of conventional oxygen therapy Use
timeFrame: Day 1 through Day 29
measure: Duration of new conventional oxygen therapy use
timeFrame: Day 1 through Day 29
measure: Duration of Non-invasive Ventilation or High Flow Oxygen Use
timeFrame: Day 1 through Day 29
measure: Duration of New Non-invasive Ventilation or High Flow Oxygen Use
timeFrame: Day 1 through Day 29
measure: Duration of Mechanical Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
timeFrame: Day 1 through Day 29
measure: Percentage of Participants Requiring New Oxygen Use
timeFrame: Day 1 through Day 29
measure: Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use
timeFrame: Day 1 through Day 29
measure: Percentage of Participants Requiring Ventilator or ECMO Use
timeFrame: Day 1 through Day 29
measure: Incidents of post-COVID-19 related symptoms at Day 29
timeFrame: Day 29
measure: Incidents of post-COVID-19 related symptoms at Day 60
timeFrame: Day 60
measure: Percentage of participants with post-COVID-19 related symptoms at Day 29
timeFrame: Day 29
measure: Percentage of participants with post-COVID-19 related symptoms at Day 60
timeFrame: Day 60
measure: Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
timeFrame: Day 1 through Day 29
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: Day 1 through Day 29
measure: Percentage of Participants Discontinued or Temporarily Suspended From Investigational dietary supplements
timeFrame: Day 1 through Day 14
measure: Change From Baseline in Alanine Transaminase (ALT)
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in Aspartate Transaminase (AST)
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in Total Bilirubin
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in Creatinine
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in Glucose
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in Hemoglobin
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in Platelets
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in White Blood Cell Count (WBC)
timeFrame: Days 1, 7, 14 and 29
measure: Change From Baseline in Lymphocytes
timeFrame: Days 1, 7, 14 and 29
Other outcomes:
measure: Change From Baseline in C-Reactive Protein
timeFrame: Days 1, 7 and 14
measure: Change From Baseline in D-Dimer
timeFrame: Days 1, 7 and 14
measure: Change From Baseline in Lactate Dehydrogenase
timeFrame: Days 1, 7 and 14
measure: Change From Baseline in Ferritin
timeFrame: Days 1, 7 and 14
Locations:
city: Rubizhne
country: Ukraine
facility: The Central Hospital of Rubizhne, Infection Disease Department
state: Luhansk Region
city: Kharkiv
country: Ukraine
facility: Municipal Kharkiv Regional Infectious Diseases Clinical Hospital
Study officials:
References:
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.
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.
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.