This randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with 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
Inclusion Criteria:
- Be male or female, ≥18 years of age
- Be willing and able to give informed consent
- Screening/Randomization telemedicine visit within 2 days of testing positive test for
COVID-19
- Having self-reported fever or cough for not more than 72 hours prior to COVID-19
testing
- Mild to moderate COVID-19
- Able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
- 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
- History of chronic lung disease
- Ongoing requirement for oxygen therapy
- Shortness of breath in resting position
- Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) /
Continuous Positive Airway Pressure (CPAP)
- Female patients who are pregnant, trying to become pregnant or lactating
- Is considered, in the opinion of the PI, to be unlikely for any reason to be able to
comply with study procedures
Healthstar Research
Hot Springs, Arkansas, United States
Axon Clinical Research
Riverside, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Vista Health Research
Miami, Florida, United States
Bio-Medical Research
Miami, Florida, United States
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Centex Studies, Inc. - Lake Charles
Lake Charles, Louisiana, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Wake Research - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, United States
Carolina Institute For Clinical Research
Fayetteville, North Carolina, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
TruCare Internal Medicine and Infectious Diseases
DuBois, Pennsylvania, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
Global Medical Research
DeSoto, Texas, United States
Centex Studies
Houston, Texas, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, United States
Mark Wingertzahn, PhD, Study Director
Kaleido Biosciences