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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414124
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

Study Description
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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
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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
Actual Primary Completion Date : February 2, 2021
Actual Study Completion Date : February 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414124


Locations
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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
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Study Director: Mark Wingertzahn, PhD Kaleido Biosciences
More Information
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Responsible Party: Kaleido Biosciences
ClinicalTrials.gov Identifier: NCT04414124    
Other Study ID Numbers: K031-120
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases