Clinical trial NCT04847349: Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial
Official title: Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Probiotics
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Vault Health, Inc.
name: Danisco USA Inc.
First posted: 2021-04-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2.

Detailed description: This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses (a standard dose and a high dose) of a combination of live microbials (probiotics), currently marketed in food (including products labeled as dietary supplements), given daily for 21 days to boost the immunity of unvaccinated, generally healthy persons ages 18-60 with prior confirmed SARS-CoV-2 infection. Data collected will include demographics, comorbidities, medications, information about prior SARS-CoV-2 infection, and self-reported symptoms and adverse events (AEs). Biospecimens (saliva, nasal wash, blood, and stool) will be collected at baseline and days 21 and 42 for analysis.

Eligibility criteria: Inclusion Criteria:

* Healthy adults (any gender, ages 18 to 60 years old) in good general health, based on medical history
* SARS-CoV-2 infection \>4 months prior confirmed by a positive polymerase chain reaction (PCR) or antigen test
* Body mass index (BMI) of 18.5-39.9 kg/m2
* Agreement to comply with the protocol and study restrictions
* Access to internet in addition to willingness and ability to use web-based questionnaires
* Available for all study visits
* English-speaking

Exclusion Criteria:

* Recent infection with coronavirus disease-2019 (COVID-19) (newly positive PCR or antigen test within prior 4 months)
* Prior receipt of antibody therapies (convalescent or monoclonal) towards COVID-19
* Prior receipt of vaccines against COVID-19
* Prior or current participation in a clinical trial of vaccines against COVID-19
* Scheduled to receive a vaccine against COVID-19 in the following month
* Regular use of any live microbial (probiotic) supplements
* Any acute or chronic respiratory tract disease besides mild to moderate asthma
* Any diagnosed immunodeficiency
* Current use of immunosuppressive drugs
* Any diagnosis of chronic gut disease, such as inflammatory bowel disease or irritable bowel syndrome
* Pregnancy or breastfeeding
* Recent use of antibiotics
* Current addiction to alcohol, drugs, or medications

Primary outcomes:
measure: Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG)
timeFrame: between baseline and day 21 (day 1 is the first day of taking the investigational product)
Secondary outcomes:
measure: Change in the titer of serum anti-SARS-CoV-2 IgG
timeFrame: between baseline and day 42
measure: Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody
timeFrame: between baseline and days 21 and 42
measure: Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody
timeFrame: between baseline and days 21 and 42
measure: In-vitro changes in cytokine release in response to stimulation of peripheral blood mononuclear cells with SARS-CoV-2 peptides
timeFrame: between baseline and days 21 and 42
measure: Serum cytokine levels
timeFrame: between baseline and days 21 and 42
measure: Adverse events
timeFrame: up to 10 weeks
measure: Change in any baseline symptoms from prior SARS-CoV-2 infection
timeFrame: up to 6 weeks
measure: New (repeat) SARS-CoV-2 infections
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Daniel B Horton, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: