Official Title
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
Brief Summary

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.

Completed
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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

Kaleido Biosciences
NCT Number
Keywords
Microbiome
Covid-19
Corona Virus
Corona Virus Disease
Kaleido
Kaleido Biosciences
KB109
Oligosaccharide
Glycan
Pathogens
Microbiome metabolic therapy
MMT
Supportive Self Care
SSC
telemedicine
MeSH Terms
COVID-19