COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04762628

Saisei Pharma

Not reported

2021-02-21

Completed

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

inclusion criteria: 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

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

3

Saisei Pharma

18

100

Ukraine

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

600

14-day Participant Mortality;29-day Participant Mortality;The time to basic clinical improvement and to recovery defined as the following

None

Not reported

[{"arm_notes": "", "treatment_id": 764, "treatment_name": "Maf capsules", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 772, "treatment_name": "M capsules", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]