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

Sponsor

Kaleido Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT04486482

Collaborator

(none)

Enrollment

Locations

Arms

2.5

Actual Duration (Months)

4.1

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild-to-Moderate COVID-19	Other: KB109 + Self Supportive Care (SSC) Other: Self Supportive Care (SSC) Alone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Jan 12, 2021

Actual Primary Completion Date :

Mar 30, 2021

Actual Study Completion Date :

Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: KB109 + Self Supportive Care (SSC)	Other: KB109 + Self Supportive Care (SSC) KB109 is a novel glycan
Other: Self Supportive Care (SSC) Alone	Other: Self Supportive Care (SSC) Alone Self Supportive Care (SSC) Alone

Arm

Intervention/Treatment

Other: KB109 + Self Supportive Care (SSC)

Other: KB109 + Self Supportive Care (SSC)

KB109 is a novel glycan

Other: Self Supportive Care (SSC) Alone

Other: Self Supportive Care (SSC) Alone

Self Supportive Care (SSC) Alone

Outcome Measures

Primary Outcome Measures

Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) [Day 1 to Day 35]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Advanced Pharma CR, LLC	Miami	Florida	United States	33147
6	Hope Clinical Trials	Miami	Florida	United States	33165
7	Kendall South Medical Center, Inc.	Miami	Florida	United States	33185
8	Quad Clinical Research	Chicago	Illinois	United States	60605
9	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
10	Inquest Research	Baytown	Texas	United States	77521
11	Olympus Family Medicine	Salt Lake City	Utah	United States	84117
12	South Ogden Family Medicine Center	South Ogden	Utah	United States	84405