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.
Other: KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan
Other: Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone
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
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