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

Completed · Not applicable

Conditions studied: Mild-to-moderate COVID-19

In brief

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.

Key facts

Study ID

NCT04414124

Run by

Kaleido Biosciences

People needed

350

Starts

2020-08-02

Expected to finish

2021-02-02

Last updated by the study team

2021-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Healthstar Research — Hot Springs, Arkansas, United States
• Axon Clinical Research — Riverside, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Vista Health Research — Miami, Florida, United States
• Bio-Medical Research — Miami, Florida, United States
• Mount Vernon Clinical Research — Atlanta, Georgia, United States
• Centex Studies, Inc. - Lake Charles — Lake Charles, Louisiana, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Wake Research - Clinical Research Center of Nevada, LLC — Las Vegas, Nevada, United States
• Carolina Institute For Clinical Research — Fayetteville, North Carolina, United States
• M3 Wake Research, Inc — Raleigh, North Carolina, United States
• TruCare Internal Medicine and Infectious Diseases — DuBois, Pennsylvania, United States
• ClinSearch LLC — Chattanooga, Tennessee, United States
• Global Medical Research — DeSoto, Texas, United States
• Centex Studies — Houston, Texas, United States
• Infectious Diseases Associates of Central Virginia — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.