Official Title
An Exploratory, Open Label, Clinical Study to Evaluate the Physiologic Effects of KB109 in Adult Patients With Mild-to-Moderate COVID-19 on Gut Microbiota Structure and Function in the Outpatient Setting
Brief Summary

This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.

Completed
Mild-to-moderate COVID-19

Other: KB109 + Self Supportive Care (SSC)

KB109 is a novel glycan

Other: Self Supportive Care (SSC) Alone

Self Supportive Care (SSC) Alone

Eligibility Criteria

To be considered for enrollment into this study, each patient must meet all of the
following Inclusion Criteria:

1. Be male or female, ≥18 years of age

2. Be willing and able to give informed consent

3. Screening/Randomization telemedicine visit within 2 days of testing positive test for
COVID-19

4. Having self-reported fever or cough for not more than 72 hours prior to COVID-19
testing

5. Mild to moderate COVID-19

6. Able to adhere to the study visit schedule and other protocol requirements

Patients who meet any of the following Exclusion Criteria at the Randomization Visit will
not be enrolled into the study:

1. Patients who are hospitalized for in-patient treatment or currently being evaluated
for potential hospitalization at the time of informed consent for conditions other
than COVID-19

2. History of chronic lung disease

3. Ongoing requirement for oxygen therapy

4. Shortness of breath in resting position

5. Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) /
Continuous Positive Airway Pressure (CPAP)

6. Female patients who are pregnant, trying to become pregnant or lactating.

7. Is considered, in the opinion of the PI, to be unlikely for any reason to be able to
comply with study procedures

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Cullman Clinical Trials
Cullman, Alabama, United States

American Institute of Research
Los Angeles, California, United States

Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States

Next Phase Research Alliance
Boca Raton, Florida, United States

Advanced Pharma CR, LLC
Miami, Florida, United States

Hope Clinical Trials
Miami, Florida, United States

Kendall South Medical Center, Inc.
Miami, Florida, United States

Quad Clinical Research
Chicago, Illinois, United States

Massachusetts General Hospital
Boston, Massachusetts, United States

Inquest Research
Baytown, Texas, United States

Olympus Family Medicine
Salt Lake City, Utah, United States

South Ogden Family Medicine Center
South Ogden, Utah, United States

Mark Wingertzahn, PhD, Study Director
Kaleido Biosciences

Kaleido Biosciences
NCT Number
Keywords
Microbiome
Covid-19
Corona Virus
Corona Virus Disease
Kaleido
Kaleido Biosciences
KB109
Oligosaccharides
Glycan
outpatient
Pathogens
Microbiome metabolic therapy
MMT
telemedicine
MeSH Terms
COVID-19