Status:
COMPLETED
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
Lead Sponsor:
Kaleido Biosciences
Conditions:
Mild-to-moderate COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04414124
Start Date
August 2 2020
End Date
February 2 2021
Last Update
August 13 2021
Active Locations (16)
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1
Healthstar Research
Hot Springs, Arkansas, United States, 71913
2
Axon Clinical Research
Riverside, California, United States, 92505
3
Medical Center for Clinical Research
San Diego, California, United States, 92108
4
Vista Health Research
Miami, Florida, United States, 33176