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

Mild-to-Moderate COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486482
• Other study ID #: K032-120
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: March 30, 2021

Study information

• Verified date: August 2021
• Source: Kaleido Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mild-to-Moderate COVID-19

Intervention

Other:
• KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan
• Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone

Locations

Country	Name	City	State
United States	Inquest Research	Baytown	Texas
United States	Next Phase Research Alliance	Boca Raton	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Quad Clinical Research	Chicago	Illinois
United States	Cullman Clinical Trials	Cullman	Alabama
United States	American Institute of Research	Los Angeles	California
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	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Olympus Family Medicine	Salt Lake City	Utah
United States	South Ogden Family Medicine Center	South Ogden	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Kaleido Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)		Day 1 to Day 35
Secondary	Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.	Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone	Day 1 to Day 35