Mild-to-Moderate COVID-19
Conditions
Keywords
Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharides, Glycan, Outpatient, Pathogens, Microbiome Metabolic Therapy, MMT, Telemedicine
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.
Interventions
KB109 is a novel glycan
Self Supportive Care (SSC) Alone
Sponsors
Kaleido Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) | Day 1 to Day 35 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing. | Day 1 to Day 35 | Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone |
Countries
United States
Outcome results
None listed