Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
KB109 + Self Supportive Care (SSC)
  • Other: KB109 + Self Supportive Care (SSC)
    KB109 is a novel glycan
Other
Self Supportive Care (SSC) Alone
  • Other: Self Supportive Care (SSC) Alone
    Self Supportive Care (SSC) Alone

More Details

Status
Completed
Sponsor
Kaleido Biosciences

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.