Monitoring the Efficacy of a Probiotic Dietary Supplement SmartProbio C in Patients With Severe COVID-19 Infection

Medi Pharma Vision

Status

Completed

Conditions

COVID-19

Treatments

Dietary Supplement: Placebo

Dietary Supplement: SmartProbio C

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05474144

123666

Details and patient eligibility

About

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/>30), 2) age (<=65/>65), 3) CRP (C-reactive protein; <=100/>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

Enrollment

83 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.