Clinical trial NCT04486482: A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild-to-Moderate COVID-19
Keywords: Microbiome
COVID-19
Corona Virus
Corona Virus Disease
Kaleido
Kaleido Biosciences
KB109
Oligosaccharides
Glycan
Outpatient
Pathogens
Microbiome Metabolic Therapy
MMT
Telemedicine
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
timeFrame: Day 1 to Day 35
Secondary outcomes:
measure: Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.
timeFrame: Day 1 to Day 35
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: Boca Raton
country: United States
facility: Next Phase Research Alliance
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Hope Clinical Trials
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Chicago
country: United States
facility: Quad Clinical Research
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Baytown
country: United States
facility: Inquest Research
state: Texas
city: Salt Lake City
country: United States
facility: Olympus Family Medicine
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine Center
state: Utah
Study officials:
affiliation: Kaleido Biosciences
name: Mark Wingertzahn, PhD
role: STUDY_DIRECTOR
References:
citation: Haran JP, Pinero JC, Zheng Y, Palma NA, Wingertzahn M. Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study. Trials. 2021 Apr 2;22(1):245. doi: 10.1186/s13063-021-05157-0.