A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
NCT ID: NCT04486482
Last Updated: 2021-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2021-01-12
2021-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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KB109 + Self Supportive Care (SSC)
KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan
Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone
Interventions
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KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan
Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Kaleido Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Wingertzahn, PhD
Role: STUDY_DIRECTOR
Kaleido Biosciences
Locations
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Cullman Clinical Trials
Cullman, Alabama, United States
American Institute of Research
Los Angeles, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
Next Phase Research Alliance
Boca Raton, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Hope Clinical Trials
Miami, Florida, United States
Kendall South Medical Center, Inc.
Miami, Florida, United States
Quad Clinical Research
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Inquest Research
Baytown, Texas, United States
Olympus Family Medicine
Salt Lake City, Utah, United States
South Ogden Family Medicine Center
South Ogden, Utah, United States
Countries
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References
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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.
Other Identifiers
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K032-120
Identifier Type: -
Identifier Source: org_study_id
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