Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762628
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2021-02-11
Brief Title:
Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules 148 mg and M Capsules 148 mg in Hospitalized COVID-19 Patients
Sponsor:
Saisei Pharma
Organization:
Saisei Pharma
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SaiseiCovUKR
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 guts 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None