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

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

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.

Study Overview

• Status: Completed
• Conditions: Mild-to-moderate COVID-19
• Intervention / Treatment: Other: KB109 + Self Supportive Care (SSC); Other: Self Supportive Care (SSC) Alone

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Healthstar Research
  • California
    • Riverside, California, United States, 92505
      • Axon Clinical Research
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
  • Florida
    • Miami, Florida, United States, 33176
      • Vista Health Research
    • Miami, Florida, United States, 33184
      • Bio-Medical Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Mount Vernon Clinical Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Centex Studies, Inc. - Lake Charles
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Wake Research - Clinical Research Center of Nevada, LLC
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Carolina Institute for Clinical Research
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • TruCare Internal Medicine and Infectious Diseases
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch LLC
  • Texas
    • DeSoto, Texas, United States, 75115
      • Global Medical Research
    • Houston, Texas, United States, 77058
      • Centex Studies
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Infectious Diseases Associates of Central Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
Change from baseline to end of intake in overall composite COVID-19 symptom score	The composite COVID-19 symptom score is the sum of the 8 cardinal COVID-19 related symptom scores (cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild: Moderately severe. The overall composite score ranges from 0 (no symptoms) to 24 (very severe)	Day 1 to Day 35
Time to resolution of fever	Resolution of fever is defined as from Day 1 until the day at which a patient's daily maximum temperature achieves and remains below 100.4 Degrees Fahrenheit for the rest of the intake period and for the follow-up period without an antipyretic medication.	Day 1 to Day 35
Proportion of patients with decreased oxygen saturation		Day 14, Day 35
Effect of COVID-19 symptoms on physical activities	Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.	Day 1 to Day 35
Proportion of patients requiring hospitalization		Day 1 to Day 35
Time to resolution of overall 13 COVID-19 related symptoms.	Defined as from Day 1 until the day at which the overall composite score of 13 COVID-19 related symptoms becomes 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 13 COVID-19 related symptoms is the sum of 13 COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal disturbance/symptoms, diarrhea, fatigue, nasal congestion, and chest tightness (CDC 2020). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe. The overall composite score ranges from 0 (no symptoms) to 39 (very severe).	Day 1 to Day 35
Time to resolution of overall 8 cardinal COVID-19 related symptoms.	Defined as from Day 1 until the day at which the overall composite score of 8 cardinal COVID-19 related symptoms 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 8 cardinal COVID-19 related symptoms is the sum of 8 cardinal COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat).	Day 1 to Day 35

Collaborators and Investigators

• Sponsor: Kaleido Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2020
• Primary Completion (Actual): February 2, 2021
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Microbiome; COVID-19; Corona Virus; Pathogens; Corona Virus Disease; Kaleido; Kaleido Biosciences; KB109; Glycan; MMT; SSC; Oligosaccharide; Microbiome metabolic therapy; Supportive Self Care
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: K031-120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No