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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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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.

Eligibility

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 details
    Mild-to-moderate COVID-19

NCT04414124

Kaleido Biosciences

16 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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