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CompletedNCT04486482Updated Aug 13, 2021

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

An interventional study of KB109 + Self Supportive Care (SSC) and Self Supportive Care (SSC) Alone in Mild-to-Moderate COVID-19, sponsored by Kaleido Biosciences. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-13.

Sponsored by Kaleido Biosciences · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mild-to-Moderate COVID-19

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Keywords

  • Microbiome
  • COVID-19
  • Corona Virus
  • Corona Virus Disease
  • Kaleido
  • Kaleido Biosciences
  • KB109
  • Oligosaccharides
  • Glycan
  • Outpatient
  • Pathogens
  • Microbiome Metabolic Therapy
  • MMT
  • Telemedicine
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 49 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Kaleido Biosciences is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Other
    KB109 + Self Supportive Care (SSC)

    Other: KB109 + Self Supportive Care (SSC)

  • Other
    Self Supportive Care (SSC) Alone

    Other: Self Supportive Care (SSC) Alone

Interventions

  • OtherKB109 + Self Supportive Care (SSC)

    KB109 is a novel glycan

  • OtherSelf Supportive Care (SSC) Alone

    Self Supportive Care (SSC) Alone

06

What researchers measure

Primary outcomes

  1. Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)

    Time frame: 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.

    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

07

Study locations

12 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 33810796 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04486482
Lead sponsor
Kaleido Biosciences
Responsible party
Sponsor
First posted
Jul 24, 2020
Start date
Jan 12, 2021
Primary completion
Mar 30, 2021
Completion
Mar 30, 2021
Last update
Aug 13, 2021

Study contacts

Mark Wingertzahn, PhD
study director · Kaleido Biosciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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