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

Primary Purpose

COVID-19 Respiratory Infection

Status

Completed

Phase

Not Applicable

Locations

Ukraine

Study Type

Interventional

Intervention

Probiotic

Placebo

About this trial

This is an interventional treatment trial for COVID-19 Respiratory Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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 ;
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

Sites / Locations

Hemo Medica Ukraine Ltd
Lviv State Center for Disease Control and Prevention
3rd City Clinical Hospital of Lviv

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

NordBiotic ImmunoVir, a mixute of bidido- and lactobacteria administered in a dose of 5 billion once a day for 28 days

Maltodextrine administered once a day for 28 days

Outcomes

Primary Outcome Measures

Global symptom score

Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease)

Secondary Outcome Measures

8 - point ordinal severity scale of coronavirus disease-19

World Health Organization scale; score 0 - healthy, score 8 - death

Time to recovery

Day when patient symptom score is 0

Percent of completely recovered patients

Patients with symptom score is 0

Hospitalization rate

Percent hospitalized due to COVID-19

Full Information

NCT ID

NCT04907877

First Posted

May 28, 2021

Last Updated

March 21, 2023

Sponsor

Nordic Biotic Sp. z o.o.

1. Study Identification

Unique Protocol Identification Number

NCT04907877

Brief Title

Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients

Acronym

ProCOVID

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nordic Biotic Sp. z o.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Respiratory Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm Description

NordBiotic ImmunoVir, a mixute of bidido- and lactobacteria administered in a dose of 5 billion once a day for 28 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Maltodextrine administered once a day for 28 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic

Intervention Description

Probiotic will be taken 1 time a day before breakfast for 28 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo will be taken 1 time a day before breakfast for 28 days.

Primary Outcome Measure Information:

Title

Global symptom score

Description

Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease)

Time Frame

10 days

Secondary Outcome Measure Information:

Title

8 - point ordinal severity scale of coronavirus disease-19

Description

World Health Organization scale; score 0 - healthy, score 8 - death

Time Frame

28 days

Title

Time to recovery

Description

Day when patient symptom score is 0

Time Frame

28 days

Title

Percent of completely recovered patients

Description

Patients with symptom score is 0

Time Frame

28 days

Title

Hospitalization rate

Description

Percent hospitalized due to COVID-19

Time Frame

28 days

Other Pre-specified Outcome Measures:

Title

Anti-SARS-CoV-2 antibodies IgG response

Description

Antibody titer to NCP and spike antigen

Time Frame

Days 0-5, day 28-35, month 6th

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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 ; 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zoriana Hoda, MD

Organizational Affiliation

Lviv State Laboratory Center, Ministry of Health of Ukraine

Official's Role

Study Director

Facility Information:

Facility Name

Hemo Medica Ukraine Ltd

City

Uzhhorod

State/Province

Zakarpatska

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Lviv State Center for Disease Control and Prevention

City

Lviv

ZIP/Postal Code

79014

Country

Ukraine

Facility Name

3rd City Clinical Hospital of Lviv

City

Lviv

ZIP/Postal Code

79016

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Not applicable as not decided yet

Citations:

PubMed Identifier

32287140

Citation

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Results Reference

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32406522

Citation

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Results Reference

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Citation

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Results Reference

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Citation

Van Tassell ML, Miller MJ. Lactobacillus adhesion to mucus. Nutrients. 2011 May;3(5):613-36. doi: 10.3390/nu3050613. Epub 2011 May 20.

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Citation

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Citation

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Citation

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Citation

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Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients

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