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

August 12, 2021 updated by: Kaleido Biosciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
    • California
      • Los Angeles, California, United States, 90017
        • American Institute of Research
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Cucamonga Clinical Research
    • Florida
      • Boca Raton, Florida, United States, 33166
        • Next Phase Research Alliance
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC
      • Miami, Florida, United States, 33185
        • Kendall South Medical Center, Inc.
      • Miami, Florida, United States, 33165
        • Hope Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60605
        • Quad Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Research
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Olympus Family Medicine
      • South Ogden, Utah, United States, 84405
        • South Ogden Family Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: KB109 + Self Supportive Care (SSC)
Other: KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan
Other: Self Supportive Care (SSC) Alone
Other: Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
Time Frame: Day 1 to Day 35
Day 1 to Day 35

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 to Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaleido Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K032-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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