A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function

Not Applicable

Completed

• Conditions: Mild-to-Moderate COVID-19
• Interventions: Other: KB109 + Self Supportive Care (SSC); Other: Self Supportive Care (SSC) Alone

• Registration Number: NCT04486482
• Lead Sponsor: Kaleido Biosciences

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 available

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-24
• Study Start: 2021-01-12
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KB109 + Self Supportive Care (SSC)	KB109 + Self Supportive Care (SSC)	-
Self Supportive Care (SSC) Alone	Self Supportive Care (SSC) Alone	-

Primary Outcome Measures

Name	Time	Method
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)	Day 1 to Day 35

Secondary Outcome Measures

Name	Time	Method
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.	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

Trial Locations

Locations (12)

American Institute of Research; 🇺🇸 Los Angeles, California, United States

Cullman Clinical Trials; 🇺🇸 Cullman, Alabama, United States

Rancho Cucamonga Clinical Research; 🇺🇸 Rancho Cucamonga, California, United States

Kendall South Medical Center, Inc.; 🇺🇸 Miami, Florida, United States

Next Phase Research Alliance; 🇺🇸 Boca Raton, Florida, United States

Quad Clinical Research; 🇺🇸 Chicago, Illinois, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States

Hope Clinical Trials; 🇺🇸 Miami, Florida, 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