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

Kaleido Biosciences

Status

Completed

Conditions

Mild-to-moderate COVID-19

Treatments

Other: KB109 + Self Supportive Care (SSC)

Other: Self Supportive Care (SSC) Alone

Study type

Interventional

Funder types

Industry

Identifiers

NCT04414124

K031-120

Details and patient eligibility

About

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.

Enrollment

350 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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