Clinical trial NCT04907877: Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients
Official title: Role of Nutritional Support With Probiotics in Adult Outpatients With Symptomatic COVID-19: a Randomized Dietary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Respiratory Infection
Lead sponsor: Nordic Biotic Sp. z o.o.
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Global symptom score
timeFrame: 10 days
Secondary outcomes:
measure: 8 - point ordinal severity scale of coronavirus disease-19
timeFrame: 28 days
measure: Time to recovery
timeFrame: 28 days
measure: Percent of completely recovered patients
timeFrame: 28 days
measure: Hospitalization rate
timeFrame: 28 days
Other outcomes:
measure: Anti-SARS-CoV-2 antibodies IgG response
timeFrame: Days 0-5, day 28-35, month 6th
Locations:
city: Uzhhorod
country: Ukraine
facility: Hemo Medica Ukraine Ltd
state: Zakarpatska
city: Lviv
country: Ukraine
facility: Lviv State Center for Disease Control and Prevention
city: Lviv
country: Ukraine
facility: 3rd City Clinical Hospital of Lviv
Study officials:
affiliation: Lviv State Laboratory Center, Ministry of Health of Ukraine
name: Zoriana Hoda, MD
role: STUDY_DIRECTOR
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