monitoring the efficacy of a probiotic dietary supplement smartprobio c in patients with severe covid-19 infection

Conditions: COVID-19

Summary: the aim of the study is to test the efficacy of the probiotic smartprobio c in patients with a severe course of covid-19 infection. patients were randomly divided into two arms between the probiotic group and the placebo group. they were further divided into four groups according to 1) bmi (body mass index; \ 30), 2) age (\ 65), 3) crp (c-reactive protein; \ 100), 4) chronic lung disease (yes/no). gut microbiome analysis and its changes in selected parameters (amount of lactobacilli, bifidobacteria, akkermansia, proteobacteria, firmicutes/bacteroidetes ratio) were chosen as the primary endpoint. other assessed indicators include: * tracking of time to clinical improvement by two points on a seven-point ordinal scale for clinical improvement according to r\&d blueprint: covid-19 therapeutic trial synopsis (who, 2020) or time to hospital discharge (whichever comes first) * monitoring the length of oxygen dependence * monitoring of laboratory markers of inflammation - serum peripheral blood crp levels * monitoring of mortality


Eligibility criteria:
inclusion criteria: * the subject is willing and able to provide informed consent prior to any study procedure. * age at the time of screening between 18 and 85 years inclusive. * coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) or immunochromatographic detection of sars cov-2 specific antigens no more than three days prior to randomization. * covid-19 symptoms lasting less than or equal to seven days, including. * subject is currently hospitalized and requires medical care due to covid-19 disease and was admitted at most two days prior to randomization. * peripheral blood oxygen saturation \<94% on air (as measured by pulse oximetry or arterial blood sampling) at the time of inclusion in the trial. exclusion criteria: * participation in any other clinical trial of an experimental treatment for covid-19 disease. * concomitant treatment of covid-19 with other non-standard-of-care medications less than 24 hours prior to initiation of the study intervention dosing (excluding remdesivir, corticosteroids, casirivimab, imdevimab, or bamlanivimab). * immunosuppressant treatment three months prior to hospital admission (excluding topical and inhaled corticosteroids or systemically administered corticosteroids at a dose equivalent to \<40 mg prednisone) * necessity of invasive pulmonary ventilation. * patients with known primary or secondary immunodeficiency. * history of crohn's disease or ulcerative colitis. * abnormal screening laboratory results - laboratory abnormalities that, in the opinion of the investigator, will interfere with completion of participation in the clinical trial or will interfere with the results of the trial. * participation in another clinical trial of a drug or medical device, or less than 30 days have elapsed since the completion of participation in another trial or use of the investigational drug or device. * other probiotic supplementation. * hypersensitivity to any ingredient of a product administered during a clinical trial. * women who are pregnant or breastfeeding. * patients with preterminal and terminal organ failure (copd gold 3 and 4, ckd g4 and g5, nyha 3 and 4). * any condition that, in the opinion of the investigator, may compromise the patient's ability to provide informed consent and/or comply with all required study procedures.

Keywords: covid-19 probiotics probiotic supplementation