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

  • STATUS
    Recruiting
  • participants needed
    400
  • sponsor
    Kaleido Biosciences
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Updated on 19 February 2024
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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.

Details
Condition Mild-to-moderate COVID-19
Age 18-100 years
Treatment KB109 + Self Supportive Care (SSC), Self Supportive Care (SSC) Alone
Clinical Study IdentifierNCT04414124
SponsorKaleido Biosciences
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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