A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
Primary Purpose
Mild-to-Moderate COVID-19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KB109 + Self Supportive Care (SSC)
Self Supportive Care (SSC) Alone
Sponsored by
About this trial
This is an interventional other trial for Mild-to-Moderate COVID-19 focused on measuring Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharides, Glycan, Outpatient, Pathogens, Microbiome Metabolic Therapy, MMT, Telemedicine
Eligibility Criteria
To be considered for enrollment into this study, each patient must meet all of the following 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
Patients who meet any of the following Exclusion Criteria at the Randomization Visit will not be enrolled into the study:
- 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
Sites / Locations
- Cullman Clinical Trials
- American Institute of Research
- Rancho Cucamonga Clinical Research
- Next Phase Research Alliance
- Advanced Pharma CR, LLC
- Hope Clinical Trials
- Kendall South Medical Center, Inc.
- Quad Clinical Research
- Massachusetts General Hospital
- Inquest Research
- Olympus Family Medicine
- South Ogden Family Medicine Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
KB109 + Self Supportive Care (SSC)
Self Supportive Care (SSC) Alone
Arm Description
Outcomes
Primary Outcome Measures
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
Secondary Outcome Measures
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.
Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486482
Brief Title
A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaleido Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild-to-Moderate COVID-19
Keywords
Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharides, Glycan, Outpatient, Pathogens, Microbiome Metabolic Therapy, MMT, Telemedicine
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KB109 + Self Supportive Care (SSC)
Arm Type
Other
Arm Title
Self Supportive Care (SSC) Alone
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
KB109 + Self Supportive Care (SSC)
Intervention Description
KB109 is a novel glycan
Intervention Type
Other
Intervention Name(s)
Self Supportive Care (SSC) Alone
Intervention Description
Self Supportive Care (SSC) Alone
Primary Outcome Measure Information:
Title
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
Time Frame
Day 1 to Day 35
Secondary Outcome Measure Information:
Title
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.
Description
Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone
Time Frame
Day 1 to Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
To be considered for enrollment into this study, each patient must meet all of the following 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
Patients who meet any of the following Exclusion Criteria at the Randomization Visit will not be enrolled into the study:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Wingertzahn, PhD
Organizational Affiliation
Kaleido Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Rancho Cucamonga Clinical Research
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Next Phase Research Alliance
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Hope Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Quad Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Inquest Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Olympus Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
South Ogden Family Medicine Center
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33810796
Citation
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.
Results Reference
derived
Learn more about this trial
A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
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