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

NCT04762628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2023-02-27

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

MAF capsules 148 mg

enteric capsules based on enzymatically treated bovine colostrum

DIETARY_SUPPLEMENT

M capsules 148 mg

enteric capsules based on enzymatically treated bovine whey

OTHER

Standard of care

Standard of care

Sponsors & Collaborators

  • Saisei Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2021-07-05
Completion
2021-08-06

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04762628 on ClinicalTrials.gov