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
1 other identifier
interventional
350
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Shorter than P25 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
August 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2021
CompletedAugust 13, 2021
August 1, 2021
6 months
June 1, 2020
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
Day 1 to Day 35
Secondary Outcomes (7)
Change from baseline to end of intake in overall composite COVID-19 symptom score
Day 1 to Day 35
Time to resolution of fever
Day 1 to Day 35
Proportion of patients with decreased oxygen saturation
Day 14, Day 35
Effect of COVID-19 symptoms on physical activities
Day 1 to Day 35
Proportion of patients requiring hospitalization
Day 1 to Day 35
- +2 more secondary outcomes
Study Arms (2)
KB109 + Self Supportive Care (SSC)
OTHERSelf Supportive Care (SSC) Alone
OTHERInterventions
Self Supportive Care (SSC) Alone
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Healthstar Research
Hot Springs, Arkansas, 71913, United States
Axon Clinical Research
Riverside, California, 92505, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Vista Health Research
Miami, Florida, 33176, United States
Bio-Medical Research
Miami, Florida, 33184, United States
Mount Vernon Clinical Research
Atlanta, Georgia, 30328, United States
Centex Studies, Inc. - Lake Charles
Lake Charles, Louisiana, 70601, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Wake Research - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, 89104, United States
Carolina Institute For Clinical Research
Fayetteville, North Carolina, 28304, United States
M3 Wake Research, Inc
Raleigh, North Carolina, 27612, United States
TruCare Internal Medicine and Infectious Diseases
DuBois, Pennsylvania, 15801, United States
ClinSearch LLC
Chattanooga, Tennessee, 37421, United States
Global Medical Research
DeSoto, Texas, 75115, United States
Centex Studies
Houston, Texas, 77058, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, 24501, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Wingertzahn, PhD
Kaleido Biosciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 4, 2020
Study Start
August 2, 2020
Primary Completion
February 2, 2021
Study Completion
February 2, 2021
Last Updated
August 13, 2021
Record last verified: 2021-08