Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients
- Conditions
- COVID-19 Respiratory Infection
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Probiotic
- Registration Number
- NCT04907877
- Lead Sponsor
- Nordic Biotic Sp. z o.o.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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;
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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 ;
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Drug or alcohol abuse as suspected by investigator;
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History of persistent diarrhea of any cause;
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Use of pre- or probiotics during the last 2 weeks before enrollment;
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Allergy to any components of the TDS;
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Technical difficulties to perform virtual study visits.
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Inability to perform a blood test for antibodies after 6 months
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Inability to swallow capsules, or choking / coughing while eating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Maltodextrine administered once a day for 28 days Probiotic Probiotic NordBiotic ImmunoVir, a mixute of bidido- and lactobacteria administered in a dose of 5 billion once a day for 28 days
- Primary Outcome Measures
Name Time Method Global symptom score 10 days Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease)
- Secondary Outcome Measures
Name Time Method Hospitalization rate 28 days Percent hospitalized due to COVID-19
8 - point ordinal severity scale of coronavirus disease-19 28 days World Health Organization scale; score 0 - healthy, score 8 - death
Time to recovery 28 days Day when patient symptom score is 0
Percent of completely recovered patients 28 days Patients with symptom score is 0
Trial Locations
- Locations (3)
Hemo Medica Ukraine Ltd
🇺🇦Uzhhorod, Zakarpatska, Ukraine
Lviv State Center for Disease Control and Prevention
🇺🇦Lviv, Ukraine
3rd City Clinical Hospital of Lviv
🇺🇦Lviv, Ukraine