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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

Primary Purpose

Mild-to-moderate COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KB109 + Self Supportive Care (SSC)
Self Supportive Care (SSC) Alone
Sponsored by
Kaleido Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mild-to-moderate COVID-19 focused on measuring Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Supportive Self Care, SSC, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Healthstar Research
  • Axon Clinical Research
  • Medical Center for Clinical Research
  • Vista Health Research
  • Bio-Medical Research
  • Mount Vernon Clinical Research
  • Centex Studies, Inc. - Lake Charles
  • University of Massachusetts Medical School
  • Wake Research - Clinical Research Center of Nevada, LLC
  • Carolina Institute For Clinical Research
  • M3 Wake Research, Inc
  • TruCare Internal Medicine and Infectious Diseases
  • ClinSearch LLC
  • Global Medical Research
  • Centex Studies
  • Infectious Diseases Associates of Central Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

KB109 + Self Supportive Care (SSC)

Self Supportive Care (SSC) Alone

Arm Description

Outcomes

Primary Outcome Measures

Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

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)
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.
Proportion of patients with decreased oxygen saturation
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.
Proportion of patients requiring hospitalization
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).
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).

Full Information

First Posted
June 1, 2020
Last Updated
August 12, 2021
Sponsor
Kaleido Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT04414124
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaleido Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KB109 + Self Supportive Care (SSC)
Arm Type
Other
Arm Title
Self Supportive Care (SSC) Alone
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
KB109 + Self Supportive Care (SSC)
Intervention Description
KB109 is a novel glycan
Intervention Type
Other
Intervention Name(s)
Self Supportive Care (SSC) Alone
Intervention Description
Self Supportive Care (SSC) Alone
Primary Outcome Measure Information:
Title
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
Time Frame
Day 1 to Day 35
Secondary Outcome Measure Information:
Title
Change from baseline to end of intake in overall composite COVID-19 symptom score
Description
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)
Time Frame
Day 1 to Day 35
Title
Time to resolution of fever
Description
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.
Time Frame
Day 1 to Day 35
Title
Proportion of patients with decreased oxygen saturation
Time Frame
Day 14, Day 35
Title
Effect of COVID-19 symptoms on physical activities
Description
Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.
Time Frame
Day 1 to Day 35
Title
Proportion of patients requiring hospitalization
Time Frame
Day 1 to Day 35
Title
Time to resolution of overall 13 COVID-19 related symptoms.
Description
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).
Time Frame
Day 1 to Day 35
Title
Time to resolution of overall 8 cardinal COVID-19 related symptoms.
Description
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).
Time Frame
Day 1 to Day 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Wingertzahn, PhD
Organizational Affiliation
Kaleido Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Healthstar Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Axon Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Vista Health Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Bio-Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Centex Studies, Inc. - Lake Charles
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Wake Research - Clinical Research Center of Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Carolina Institute For Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
M3 Wake Research, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
TruCare Internal Medicine and Infectious Diseases
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Facility Name
ClinSearch LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Global Medical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Centex Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Infectious Diseases Associates of Central Virginia
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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