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A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486482
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

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.

Condition or disease Intervention/treatment Phase
Mild-to-Moderate COVID-19 Other: KB109 + Self Supportive Care (SSC) Other: Self Supportive Care (SSC) Alone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
KB109 + Self Supportive Care (SSC) Other: KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan

Self Supportive Care (SSC) Alone Other: Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone




Primary Outcome Measures :
  1. Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 35 ]

Secondary Outcome Measures :
  1. Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing. [ Time Frame: Day 1 to Day 35 ]
    Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

To be considered for enrollment into this study, each patient must meet all of the following 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486482


Contacts
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Contact: Mark Wingertzahn, PhD (617) 674-9000 clinicalstudies@kaleido.com

Locations
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United States, Alabama
Cullman Clinical Trials Recruiting
Cullman, Alabama, United States, 35055
United States, California
American Institute of Research Recruiting
Los Angeles, California, United States, 90017
Rancho Cucamonga Clinical Research Recruiting
Rancho Cucamonga, California, United States, 91730
United States, Florida
Next Phase Research Alliance Recruiting
Boca Raton, Florida, United States, 33166
Advanced Pharma CR, LLC Recruiting
Miami, Florida, United States, 33147
Hope Clinical Trials Recruiting
Miami, Florida, United States, 33165
Kendall South Medical Center, Inc. Recruiting
Miami, Florida, United States, 33185
United States, Illinois
Quad Clinical Research Recruiting
Chicago, Illinois, United States, 60605
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Courtney Balliro, RN,BS,CDE    617-762-1242    cballiro@partners.org   
United States, Texas
Inquest Research Recruiting
Baytown, Texas, United States, 77521
United States, Utah
Olympus Family Medicine Recruiting
Salt Lake City, Utah, United States, 84117
South Ogden Family Medicine Center Recruiting
South Ogden, Utah, United States, 84405
Sponsors and Collaborators
Kaleido Biosciences
Investigators
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Study Director: Mark Wingertzahn, PhD Kaleido Biosciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaleido Biosciences
ClinicalTrials.gov Identifier: NCT04486482    
Other Study ID Numbers: K032-120
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaleido Biosciences:
Microbiome
COVID-19
Corona Virus
Corona Virus Disease
Kaleido
Kaleido Biosciences
KB109
Oligosaccharides
Glycan
Outpatient
Pathogens
Microbiome Metabolic Therapy
MMT
Telemedicine