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

Study Overview
=================
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.

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

Conditions
-----------------
Mild-to-Moderate COVID-19

Intervention / Treatment
-----------------
* Other: KB109 + Self Supportive Care (SSC)
* Other: Self Supportive Care (SSC) Alone


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: KB109 + Self Supportive Care (SSC)<br> | Other: KB109 + Self Supportive Care (SSC)<br>* KB109 is a novel glycan<br>|
| Other: Self Supportive Care (SSC) Alone<br> | Other: Self Supportive Care (SSC) Alone<br>* Self Supportive Care (SSC) Alone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) |  | Day 1 to Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharides, Glycan, Outpatient, Pathogens, Microbiome Metabolic Therapy, MMT, Telemedicine