A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
An Exploratory, Open Label, Clinical Study to Evaluate the Physiologic Effects of KB109 in Adult Patients With Mild-to-Moderate COVID-19 on Gut Microbiota Structure and Function in the Outpatient Setting
1 other identifier
interventional
49
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedAugust 13, 2021
August 1, 2021
3 months
July 23, 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 (1)
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.
Day 1 to Day 35
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 (12)
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
American Institute of Research
Los Angeles, California, 90017, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730, United States
Next Phase Research Alliance
Boca Raton, Florida, 33166, United States
Advanced Pharma CR, LLC
Miami, Florida, 33147, United States
Hope Clinical Trials
Miami, Florida, 33165, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
Quad Clinical Research
Chicago, Illinois, 60605, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Inquest Research
Baytown, Texas, 77521, United States
Olympus Family Medicine
Salt Lake City, Utah, 84117, United States
South Ogden Family Medicine Center
South Ogden, Utah, 84405, United States
Related Publications (1)
Haran JP, Pinero JC, Zheng Y, Palma NA, Wingertzahn M. Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study. Trials. 2021 Apr 2;22(1):245. doi: 10.1186/s13063-021-05157-0.
PMID: 33810796DERIVED
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
July 23, 2020
First Posted
July 24, 2020
Study Start
January 12, 2021
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
August 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share