Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients

Study Overview
=================
Brief Summary
-----------------
There is evidence that some types of probiotics play a role in alleviation of symptoms of acute respiratory tract infections and bursting immune response to respiratory and enteric viruses. Available data serves a rationale for the study exploring a role of nutritional support with probiotics in adult outpatients with COVID-19. Hypothesis of the study is that a proposed mixture of lactobacilli and bifidobacteria facilitate faster recovery from COVID-19 and enhance specific immune response to SARS-CoV-2 antigens.

Detailed Description
-----------------
One hundred adults with confirmed (PCR or antigen test) symptomatic COVID-19 lasting upto 5 days will be screened for the study. When the subject meets enrollment criteria, he/she will be randomized to take an investigational product (probiotic, test dietary supplement, TDS), a mixture of lactobacilli and bifidobacteria or placebo 1 time a day before breakfast for 28 days after enrollment. During observation, the patient will keep Respiratory Illness Diary. Blood serum will be collected at baseline, day 0-5 (Nurse Visit 1), after 28-35 days (Nurse visit 2), and 6 months (Nurse visit 3) for evaluation of anti-SARS-CoV-2 antibodies to nucleocapsid and spike antigents. In 3 months, investigator/family physician will collect Post-COVID-19 Questionnaire

Official Title
-----------------
Role of Nutritional Support With Probiotics in Adult Outpatients With Symptomatic COVID-19: a Randomized Dietary Study

Conditions
-----------------
COVID-19 Respiratory Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 - ≤ 65 years; Male or non-pregnant female; Informed virtual pre-consent and paper signed consent forms; Confirmed symptomatic COVID-19 lasting 0-5 days; Subject understands and agrees to comply with study procedures including triple blood analysis for anti-SARS-CoV-2 IgG; Exclusion Criteria: Risk for the complicated course of COVID-19 due to: 1.1. Hypertension; 1.2. Diabetes mellitus; 1.3. Immunosuppressive conditions; 1.4. Chronic pathology of the respiratory system ; 1.5. Chronic pathology of the cardiovascular system ; 1.6. Malignant tumor ; 1.7. Systemic inflammatory connective tissue disease ; 1.8. Cerebrovascular disease ; 1.9. Chronic hepatitis. Hepatic cirrhosis; 1.10. Inflammatory bowel diseases ; 1.11. Chronic kidney disease ; Drug or alcohol abuse as suspected by investigator; History of persistent diarrhea of any cause; Use of pre- or probiotics during the last 2 weeks before enrollment; Allergy to any components of the TDS; Technical difficulties to perform virtual study visits. Inability to perform a blood test for antibodies after 6 months Inability to swallow capsules, or choking / coughing while eating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>NordBiotic ImmunoVir, a mixute of bidido- and lactobacteria administered in a dose of 5 billion once a day for 28 days | Dietary Supplement: Probiotic<br>* Probiotic will be taken 1 time a day before breakfast for 28 days.<br>|
| Placebo Comparator: Placebo<br>Maltodextrine administered once a day for 28 days | Dietary Supplement: Placebo<br>* Placebo will be taken 1 time a day before breakfast for 28 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global symptom score | Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8 - point ordinal severity scale of coronavirus disease-19 | World Health Organization scale; score 0 - healthy, score 8 - death | 28 days | 
| Time to recovery | Day when patient symptom score is 0 | 28 days | 
| Percent of completely recovered patients | Patients with symptom score is 0 | 28 days | 
| Hospitalization rate | Percent hospitalized due to COVID-19 | 28 days |