Skip to main content
OpenTrials
Completed

NCT Number: NCT04907877

Bifido- and Lactobacilli in Symptomatic Adult COVID-19 Outpatients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hemo Medica Ukraine Ltd, Uzhhorod, Zakarpatska, Ukraine

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Global symptom score

    Time frame: 10 days

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

Secondary outcomes

  1. 8 - point ordinal severity scale of coronavirus disease-19

    Time frame: 28 days

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

  2. Time to recovery

    Time frame: 28 days

    Day when patient symptom score is 0

  3. Percent of completely recovered patients

    Time frame: 28 days

    Patients with symptom score is 0

  4. Hospitalization rate

    Time frame: 28 days

    Percent hospitalized due to COVID-19

Other outcomes

  1. Anti-SARS-CoV-2 antibodies IgG response

    Time frame: Days 0-5, day 28-35, month 6th

    Antibody titer to NCP and spike antigen

Sponsors and collaborators

Lead sponsor

Nordic Biotic Sp. z o.o.

Industry

Registry information

Official study title

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

Acronym: ProCOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 1, 2021
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.