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

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
Contact: Mark Wingertzahn, PhD | (617) 674-9000 | clinicalstudies@kaleido.com |
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Study Director: | Mark Wingertzahn, PhD | Kaleido Biosciences |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Microbiome COVID-19 Corona Virus Corona Virus Disease Kaleido Kaleido Biosciences KB109 |
Oligosaccharides Glycan Outpatient Pathogens Microbiome Metabolic Therapy MMT Telemedicine |