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
Purpose
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.
Condition
- Mild-to-moderate COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Other KB109 + Self Supportive Care (SSC) |
|
|
Other Self Supportive Care (SSC) Alone |
|
Recruiting Locations
More Details
- NCT ID
- NCT04414124
- Status
- Completed
- Sponsor
- Kaleido Biosciences