Status:
COMPLETED
Trial Efficacy of Saisei Pharma Dietary Supplements MAF Capsules, 148 mg and M Capsules, 148 mg in Hospitalized COVID-19 Patients
Lead Sponsor:
Saisei Pharma
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
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 preliminar...
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 phagoc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04762628
Start Date
October 27 2020
End Date
August 6 2021
Last Update
February 27 2023
Active Locations (2)
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1
The Central Hospital of Rubizhne, Infection Disease Department
Rubizhne, Luhansk Oblast, Ukraine, 93012
2
Municipal Kharkiv Regional Infectious Diseases Clinical Hospital
Kharkiv, Ukraine, 61000