Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients (ProCOVID)

March 21, 2023 updated by: Sergei Gerasymov, MD, PhD, Nordic Biotic Sp. z o.o.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ukraine
      • Lviv, Ukraine, 79014
        • Lviv State Center for Disease Control and Prevention
      • Lviv, Ukraine, 79016
        • 3rd City Clinical Hospital of Lviv
    • Zakarpatska
      • Uzhhorod, Zakarpatska, Ukraine, 88000
        • Hemo Medica Ukraine Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global symptom score
Time Frame: 10 days
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
Time Frame: 28 days
World Health Organization scale; score 0 - healthy, score 8 - death
28 days
Time to recovery
Time Frame: 28 days
Day when patient symptom score is 0
28 days
Percent of completely recovered patients
Time Frame: 28 days
Patients with symptom score is 0
28 days
Hospitalization rate
Time Frame: 28 days
Percent hospitalized due to COVID-19
28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-SARS-CoV-2 antibodies IgG response
Time Frame: Days 0-5, day 28-35, month 6th
Antibody titer to NCP and spike antigen
Days 0-5, day 28-35, month 6th

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Biotic Sp. z o.o.

Investigators

  • Study Director: Zoriana Hoda, MD, Lviv State Laboratory Center, Ministry of Health of Ukraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-Resp-CoV-2-A0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not applicable as not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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