Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486482
Recruitment Status : Completed
First Posted : July 24, 2020
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

Tracking Information
First Submitted Date  ICMJE July 23, 2020
First Posted Date  ICMJE July 24, 2020
Last Update Posted Date August 13, 2021
Actual Study Start Date  ICMJE January 12, 2021
Actual Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 35 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Mild-to-Moderate COVID-19
Intervention  ICMJE
  • Other: KB109 + Self Supportive Care (SSC)
    KB109 is a novel glycan
  • Other: Self Supportive Care (SSC) Alone
    Self Supportive Care (SSC) Alone
Study Arms  ICMJE
  • KB109 + Self Supportive Care (SSC)
    Intervention: Other: KB109 + Self Supportive Care (SSC)
  • Self Supportive Care (SSC) Alone
    Intervention: Other: Self Supportive Care (SSC) Alone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2021)
49
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2020)
50
Actual Study Completion Date  ICMJE March 30, 2021
Actual Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04486482
Other Study ID Numbers  ICMJE K032-120
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaleido Biosciences
Study Sponsor  ICMJE Kaleido Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Wingertzahn, PhD Kaleido Biosciences
PRS Account Kaleido Biosciences
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP