COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05474144

Petr Rysavka

Not reported

2022-07-26

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

Medi Pharma Vision

18

85

Czech Republic

Severe disease at enrollment

6: Severe disease at enrollment

83

Gut microbiome

None

Not reported

[{"arm_notes": "nan", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]