A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19
NCT ID: NCT04414124
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
350 participants
INTERVENTIONAL
2020-08-02
2021-02-02
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
* 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.
Exclusion Criteria
* 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
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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Healthstar Research
Hot Springs, Arkansas, United States
Axon Clinical Research
Riverside, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Vista Health Research
Miami, Florida, United States
Bio-Medical Research
Miami, Florida, United States
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Centex Studies, Inc. - Lake Charles
Lake Charles, Louisiana, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Wake Research - Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, United States
Carolina Institute For Clinical Research
Fayetteville, North Carolina, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
TruCare Internal Medicine and Infectious Diseases
DuBois, Pennsylvania, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
Global Medical Research
DeSoto, Texas, United States
Centex Studies
Houston, Texas, United States
Infectious Diseases Associates of Central Virginia
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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K031-120
Identifier Type: -
Identifier Source: org_study_id
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