Clinical trial NCT05474144: Monitoring the Efficacy of a Probiotic Dietary Supplement SmartProbio C in Patients With Severe COVID-19 Infection
Official title: A Two-arm, Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy of the Probiotic Dietary Supplement SmartProbio C in the Supportive Supplementation of Patients With a Complicated Course of COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
probiotics
probiotic supplementation
Lead sponsor: Medi Pharma Vision
Sponsor class: INDUSTRY
Collaborators: name: Veterinary Research Institute
name: Brno University Hospital
First posted: 2022-07-26
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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/\>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


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.

Primary outcomes:
measure: Gut microbiome
timeFrame: The first sample was taken at the beginning of hospitalization before the start of supplementation, the second at discharge from the hospital, but not later than on the 14th day of hospitalization.
Secondary outcomes:
measure: Length of hospitalisation
timeFrame: From the date of admission to hospital until discharge from hospital or above defined two point improvement, whichever comes first
measure: Monitoring the length of oxygen dependence
timeFrame: From the beginning of the provision of HFOT (high flow oxygen therapy) to the end of the provision of HFOT
measure: CRP (C-reactive protein) monitoring
timeFrame: On the first day of admission to hospital and on the day of hospital discharge, but no later than 14th day
measure: Monitoring mortality rates
timeFrame: From the date of admission to hospital until discharge from hospital or death, whichever comes first
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Medi Pharma Vision
city: Brno
country: Czechia
facility: Brno University Hospital
Study officials:
affiliation: Medi Pharma Vision
name: Petr Rysavka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Xu K, Cai H, Shen Y, Ni Q, Chen Y, Hu S, Li J, Wang H, Yu L, Huang H, Qiu Y, Wei G, Fang Q, Zhou J, Sheng J, Liang T, Li L. [Management of COVID-19: the Zhejiang experience]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2020 Feb 21;49(2):147-157. doi: 10.3785/j.issn.1008-9292.2020.02.02. Chinese.
citation: Nguyen QV, Chong LC, Hor YY, Lew LC, Rather IA, Choi SB. Role of Probiotics in the Management of COVID-19: A Computational Perspective. Nutrients. 2022 Jan 10;14(2):274. doi: 10.3390/nu14020274.