CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 600 enrolled
Drug / intervention
MAF capsules 148 mg +2 moredietary
Likely dose
MAF capsules 148 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04762628
NCT04762628N/ACompleted

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

Saisei Pharma·interventional·Posted Feb 21, 2021·Updated Feb 27, 2023

In Brief

A clinical study evaluating MAF capsules 148 mg, M capsules 148 mg, and 1 other intervention for Covid19. Completed, enrolled 600 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesUkraine
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 21, 2021
Enrollment StartOct 27, 2020
Primary CompletionJul 5, 2021
Study CompletionAug 6, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.4 years ago

Interventions

MAF capsules 148 mgdietary

enteric capsules based on enzymatically treated bovine colostrum

M capsules 148 mgdietary

enteric capsules based on enzymatically treated bovine whey

Standard of careother

Standard of care