Status:
COMPLETED
A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
Lead Sponsor:
Kaleido Biosciences
Conditions:
Mild-to-Moderate COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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 ou...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04486482
Start Date
January 12 2021
End Date
March 30 2021
Last Update
August 13 2021
Active Locations (12)
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1
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
2
American Institute of Research
Los Angeles, California, United States, 90017
3
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States, 91730
4
Next Phase Research Alliance
Boca Raton, Florida, United States, 33166