Status:
COMPLETED
Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients
Lead Sponsor:
Nordic Biotic Sp. z o.o.
Conditions:
COVID-19 Respiratory Infection
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
- Risk for the complicated course of COVID-19 due to:
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04907877
Start Date
December 1 2021
End Date
March 1 2023
Last Update
March 22 2023
Active Locations (3)
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1
Hemo Medica Ukraine Ltd
Uzhhorod, Zakarpatska, Ukraine, 88000
2
Lviv State Center for Disease Control and Prevention
Lviv, Ukraine, 79014
3
3rd City Clinical Hospital of Lviv
Lviv, Ukraine, 79016