COVID-19 Respiratory Infection
Conditions
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
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic will be taken 1 time a day before breakfast for 28 days.
DIETARY_SUPPLEMENTPlacebo
Placebo will be taken 1 time a day before breakfast for 28 days.
Sponsors
Nordic Biotic Sp. z o.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 - ≤ 65 years; 2. Male or non-pregnant female; 3. Informed virtual pre-consent and paper signed consent forms; 4. Confirmed symptomatic COVID-19 lasting 0-5 days; 5. Subject understands and agrees to comply with study procedures including triple blood analysis for anti-SARS-CoV-2 IgG;
Exclusion criteria
1. 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 ; 2. Drug or alcohol abuse as suspected by investigator; 3. History of persistent diarrhea of any cause; 4. Use of pre- or probiotics during the last 2 weeks before enrollment; 5. Allergy to any components of the TDS; 6. Technical difficulties to perform virtual study visits. 7. Inability to perform a blood test for antibodies after 6 months 8. Inability to swallow capsules, or choking / coughing while eating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global symptom score | 10 days | Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anti-SARS-CoV-2 antibodies IgG response | Days 0-5, day 28-35, month 6th | Antibody titer to NCP and spike antigen |
Countries
Ukraine
Outcome results
None listed