Clinical trial NCT04414124: A Clinical Study to Assess the Natural History of COVID-19 and Effects of KB109 and Supportive Self-care in Outpatients With Mild-to-moderate COVID-19
Official title: A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19
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
Oligosaccharide
Glycan
Pathogens
Microbiome metabolic therapy
MMT
Supportive Self Care
SSC
Telemedicine
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 350
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 randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19.


Eligibility criteria: 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
timeFrame: Day 1 to Day 35
Secondary outcomes:
measure: Change from baseline to end of intake in overall composite COVID-19 symptom score
timeFrame: Day 1 to Day 35
measure: Time to resolution of fever
timeFrame: Day 1 to Day 35
measure: Proportion of patients with decreased oxygen saturation
timeFrame: Day 14, Day 35
measure: Effect of COVID-19 symptoms on physical activities
timeFrame: Day 1 to Day 35
measure: Proportion of patients requiring hospitalization
timeFrame: Day 1 to Day 35
measure: Time to resolution of overall 13 COVID-19 related symptoms.
timeFrame: Day 1 to Day 35
measure: Time to resolution of overall 8 cardinal COVID-19 related symptoms.
timeFrame: Day 1 to Day 35
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Healthstar Research
state: Arkansas
city: Riverside
country: United States
facility: Axon Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Miami
country: United States
facility: Vista Health Research
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Lake Charles
country: United States
facility: Centex Studies, Inc. - Lake Charles
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Las Vegas
country: United States
facility: Wake Research - Clinical Research Center of Nevada, LLC
state: Nevada
city: Fayetteville
country: United States
facility: Carolina Institute For Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: DuBois
country: United States
facility: TruCare Internal Medicine and Infectious Diseases
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch LLC
state: Tennessee
city: DeSoto
country: United States
facility: Global Medical Research
state: Texas
city: Houston
country: United States
facility: Centex Studies
state: Texas
city: Lynchburg
country: United States
facility: Infectious Diseases Associates of Central Virginia
state: Virginia
Study officials:
affiliation: Kaleido Biosciences
name: Mark Wingertzahn, PhD
role: STUDY_DIRECTOR
References: