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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Dietary Supplement: MAF capsules 148 mg; Dietary Supplement: M capsules 148 mg; Other: Standard of care

• Registration Number: NCT04762628
• Lead Sponsor: Saisei Pharma

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.

Study Timeline

• Study Start: 2020-10-27
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Primary Completion: 2021-07-05
• Study Completion: 2021-08-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAF capsules	MAF capsules 148 mg	MAF capsules 148 mg TID for 14 days + Standard of care
M capsules	M capsules 148 mg	M capsules 148 mg TID for 14 days + Standard of care
Comparison	Standard of care	Standard of care

Primary Outcome Measures

Name	Time	Method
14-day Participant Mortality	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	Day 1 through Day 29	The mortality rate will be determined as the proportion of participants who died by study Day 29
The time to basic clinical improvement and to recovery defined as the following	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

Secondary Outcome Measures

Name	Time	Method
Time to an improvement of one category from admission on 9-Point Ordinal Scale	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 evidence of infection
Duration of Non-invasive Ventilation or High Flow Oxygen Use	Day 1 through Day 29	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
Percentage of Participants Requiring New Oxygen Use	Day 1 through Day 29	The percentage of participants requiring new oxygen determined as the percentage of participants not requiring oxygen at baseline
Percentage of participants with post-COVID-19 related symptoms at Day 60	Day 60	Percentage of participants with presents post-COVID-19 related symptoms
Change From Baseline in Glucose	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 allow in-person visits after discharge.
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	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
Duration of conventional oxygen therapy Use	Day 1 through Day 29	Duration of conventional oxygen therapy use measured in days among participants who were on conventional oxygen therapy use at baseline
Duration of new conventional oxygen therapy use	Day 1 through Day 29	Duration of new conventional oxygen therapy use measured in days among participants who were not on conventional oxygen therapy use at baseline
Incidents of post-COVID-19 related symptoms at Day 29	Day 29	Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form
Change From Baseline in Total Bilirubin	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 allow in-person visits after discharge.
Change From Baseline in Hemoglobin	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 allow in-person visits after discharge.
Percentage of Participants in Each Clinical Status Category as Assessed by a 9-Point Ordinal Scale on Day 14	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
Time to an improvement of two categories from admission on 9-Point Ordinal Scale	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 evidence of infection
Percentage of participants with post-COVID-19 related symptoms at Day 29	Day 29	Percentage of participants with presents post-COVID-19 related symptoms
Percentage of Participants Discontinued or Temporarily Suspended From Investigational dietary supplements	Day 1 through Day 14	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.
Change From Baseline in Lymphocytes	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 allow in-person visits after discharge.
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	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
Duration of New Non-invasive Ventilation or High Flow Oxygen Use	Day 1 through Day 29	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
Duration of Mechanical Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use	Day 1 through Day 29	Duration of Mechanical Ventilator or ECMO Use in days among all participants to whom it will be administrated
Percentage of Participants Requiring Ventilator or ECMO Use	Day 1 through Day 29	The percentage of participants requiring Ventilator or ECMO Use
Incidents of post-COVID-19 related symptoms at Day 60	Day 60	Incidents of all post-COVID-19 symptoms, which will be reported in the post-COVID-19 questionnaire form
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)	Day 1 through Day 29	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.
Change From Baseline in Aspartate Transaminase (AST)	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 allow in-person visits after discharge.
Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use	Day 1 through Day 29	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.
Percentage of Participants Reporting Serious Adverse Events (SAEs)	Day 1 through Day 29	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.
Change From Baseline in Alanine Transaminase (ALT)	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 allow in-person visits after discharge.
Change From Baseline in Creatinine	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 allow in-person visits after discharge.
Change From Baseline in Platelets	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 allow in-person visits after discharge.
Change From Baseline in White Blood Cell Count (WBC)	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 allow in-person visits after discharge.

Trial Locations

Locations (2)

Municipal Kharkiv Regional Infectious Diseases Clinical Hospital; 🇺🇦 Kharkiv, Ukraine

The Central Hospital of Rubizhne, Infection Disease Department; 🇺🇦 Rubizhne, Luhansk Region, Ukraine