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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

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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

Tracking Information
First Submitted Date  ICMJE June 1, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date August 13, 2021
Actual Study Start Date  ICMJE August 2, 2020
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 35 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2021)
  • 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)
  • 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.
  • Proportion of patients with decreased oxygen saturation [ Time Frame: Day 14, Day 35 ]
  • 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.
  • Proportion of patients requiring hospitalization [ Time Frame: Day 1 to Day 35 ]
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2020)
  • Change from baseline to end of intake in overall composite COVID-19 symptom score [ Time Frame: Day 1 to Day 14 ]
    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 [ 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.
  • Proportion of patients with decreased oxygen saturation [ Time Frame: Day 14, Day 35 ]
  • 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.
  • Proportion of patients requiring hospitalization [ Time Frame: Day 1 to Day 35 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Mild-to-moderate COVID-19
Intervention  ICMJE
  • Other: KB109 + Self Supportive Care (SSC)
    KB109 is a novel glycan
  • Other: Self Supportive Care (SSC) Alone
    Self Supportive Care (SSC) Alone
Study Arms  ICMJE
  • KB109 + Self Supportive Care (SSC)
    Intervention: Other: KB109 + Self Supportive Care (SSC)
  • Self Supportive Care (SSC) Alone
    Intervention: Other: Self Supportive Care (SSC) Alone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2021)
350
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2020)
400
Actual Study Completion Date  ICMJE February 2, 2021
Actual Primary Completion Date February 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04414124
Other Study ID Numbers  ICMJE K031-120
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaleido Biosciences
Study Sponsor  ICMJE Kaleido Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Wingertzahn, PhD Kaleido Biosciences
PRS Account Kaleido Biosciences
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP