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

Purpose

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

  • Mild-to-moderate COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04414124
Status
Completed
Sponsor
Kaleido Biosciences