A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19

A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19

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.

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