Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients

NCT04762628 | Completed DMC

• 1 other identifier: SaiseiMAF supplements COVID
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

Covid19; Colostrum MAF; Supplements; Oxygen supply; Mortality; Clinical improvement; lymphocyte depletion prevention

Outcome Measures

Primary Outcomes (3)

• 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

  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

Secondary Outcomes (29)

• Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14

  Day 14

• Time to an improvement of one category from admission on 9-Point Ordinal Scale

  Day 1 through Day 29

• Time to an improvement of two categories from admission on 9-Point Ordinal Scale

  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

  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

  Days 3, 5, 8, 11, 14 and 29

Other Outcomes (4)

• Change From Baseline in C-Reactive Protein

  Days 1, 7 and 14

• Change From Baseline in D-Dimer

  Days 1, 7 and 14

• Change From Baseline in Lactate Dehydrogenase

  Days 1, 7 and 14

Study Arms (3)

MAF capsules

EXPERIMENTAL

MAF capsules 148 mg TID for 14 days + Standard of care

Dietary Supplement: MAF capsules 148 mg

M capsules

EXPERIMENTAL

M capsules 148 mg TID for 14 days + Standard of care

Dietary Supplement: M capsules 148 mg

Comparison

ACTIVE COMPARATOR

Standard of care

Other: Standard of care

Interventions

MAF capsules 148 mg DIETARY_SUPPLEMENT

enteric capsules based on enzymatically treated bovine colostrum

MAF capsules

M capsules 148 mg DIETARY_SUPPLEMENT

enteric capsules based on enzymatically treated bovine whey

M capsules

Standard of care OTHER

Standard of care

Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saisei Pharma: lead

Study Sites (2)

The Central Hospital of Rubizhne, Infection Disease Department

Rubizhne, Luhansk Oblast, 93012, Ukraine

Location

Municipal Kharkiv Regional Infectious Diseases Clinical Hospital

Kharkiv, 61000, Ukraine

Location

Related Publications (4)

• 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.

  PMID: 31366556 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.

  PMID: 26168491 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.

  PMID: 32013346 BACKGROUND

• 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.

  PMID: 38783176 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 21, 2021
• Study Start: October 27, 2020
• Primary Completion: July 5, 2021
• Study Completion: August 6, 2021
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Request for data will be indefinitely available
• Access Criteria: Reasonable request to investigators

Locations

UA (2)