Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04847349

Run by

Rutgers, The State University of New Jersey

People needed

54

Starts

2021-04-13

Expected to finish

2022-01-31

Last updated by the study team

2022-02-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rutgers University — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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