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

• ClinicalTrials.gov Identifier: NCT04414124
• Recruitment Status: Active, not recruiting
• First Posted: June 4, 2020
• Last Update Posted: January 22, 2021
• Sponsor: Kaleido Biosciences
• Information provided by (Responsible Party): Kaleido Biosciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mild-to-moderate COVID-19	Other: KB109 + Self Supportive Care (SSC); Other: Self Supportive Care (SSC) Alone	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: August 2, 2020
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change from baseline to end of intake in overall composite COVID-19 symptom score [ Time Frame: Day 1 to Day 35 ]
   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)
2. Time to resolution of fever [ Time Frame: Day 1 to Day 35 ]
   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.
3. Proportion of patients with decreased oxygen saturation [ Time Frame: Day 14, Day 35 ]
4. Effect of COVID-19 symptoms on physical activities [ Time Frame: Day 1 to Day 35 ]
   Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.
5. Proportion of patients requiring hospitalization [ Time Frame: Day 1 to Day 35 ]
6. Time to resolution of overall 13 COVID-19 related symptoms. [ Time Frame: Day 1 to Day 35 ]
   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).
7. Time to resolution of overall 8 cardinal COVID-19 related symptoms. [ Time Frame: Day 1 to Day 35 ]
   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).

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Arkansas

Healthstar Research

Hot Springs, Arkansas, United States, 71913

United States, California

Axon Clinical Research

Riverside, California, United States, 92505

Medical Center for Clinical Research

San Diego, California, United States, 92108

United States, Florida

Vista Health Research

Miami, Florida, United States, 33176

Bio-Medical Research

Miami, Florida, United States, 33184

United States, Georgia

Mount Vernon Clinical Research

Atlanta, Georgia, United States, 30328

United States, Louisiana

Centex Studies, Inc. - Lake Charles

Lake Charles, Louisiana, United States, 70601

United States, Massachusetts

University of Massachusetts Medical School

Worcester, Massachusetts, United States, 01655

United States, Nevada

Wake Research - Clinical Research Center of Nevada, LLC

Las Vegas, Nevada, United States, 89104

United States, North Carolina

Carolina Institute For Clinical Research

Fayetteville, North Carolina, United States, 28304

M3 Wake Research, Inc

Raleigh, North Carolina, United States, 27612

United States, Pennsylvania

TruCare Internal Medicine and Infectious Diseases

DuBois, Pennsylvania, United States, 15801

United States, Tennessee

ClinSearch LLC

Chattanooga, Tennessee, United States, 37421

United States, Texas

Global Medical Research

DeSoto, Texas, United States, 75115

Centex Studies

Houston, Texas, United States, 77058

United States, Virginia

Infectious Diseases Associates of Central Virginia

Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

Kaleido Biosciences

Investigators

• Study Director: Mark Wingertzahn, PhD; Kaleido Biosciences

More Information

• Responsible Party: Kaleido Biosciences
• ClinicalTrials.gov Identifier: NCT04414124
• Other Study ID Numbers: K031-120
• First Posted: June 4, 2020
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaleido Biosciences:

Microbiome; COVID-19; Corona Virus; Corona Virus Disease; Kaleido; Kaleido Biosciences; KB109; Oligosaccharide; Glycan; Pathogens; Microbiome metabolic therapy; MMT; Supportive Self Care; SSC; Telemedicine