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
- Conditions
- Mild-to-moderate COVID-19
- Interventions
- Other: KB109 + Self Supportive Care (SSC)Other: Self Supportive Care (SSC) Alone
- Registration Number
- NCT04414124
- Lead Sponsor
- Kaleido Biosciences
- 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 SSC alone and measures of health in outpatients with mild-to-moderate COVID-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KB109 + Self Supportive Care (SSC) KB109 + Self Supportive Care (SSC) - Self Supportive Care (SSC) Alone Self Supportive Care (SSC) Alone -
- Primary Outcome Measures
Name Time Method Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) Day 1 to Day 35
- Secondary Outcome Measures
Name Time Method Change from baseline to end of intake in overall composite COVID-19 symptom score Day 1 to Day 35 The composite COVID-19 symptom score is the sum of the 8 cardinal COVID-19 related symptom scores (cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild: Moderately severe. The overall composite score ranges from 0 (no symptoms) to 24 (very severe)
Proportion of patients requiring hospitalization Day 1 to Day 35 Time to resolution of overall 13 COVID-19 related symptoms. Day 1 to Day 35 Defined as from Day 1 until the day at which the overall composite score of 13 COVID-19 related symptoms becomes 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 13 COVID-19 related symptoms is the sum of 13 COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal disturbance/symptoms, diarrhea, fatigue, nasal congestion, and chest tightness (CDC 2020). Each COVID-19 symptom will be recorded by patients on a scale of 0: Absent, 1: Mild, 2: Moderately severe, 3: Very severe. The overall composite score ranges from 0 (no symptoms) to 39 (very severe).
Time to resolution of overall 8 cardinal COVID-19 related symptoms. Day 1 to Day 35 Defined as from Day 1 until the day at which the overall composite score of 8 cardinal COVID-19 related symptoms 0 or 1 and remains at 0 or 1 for the rest of the Intake Period and for the Follow-up Period. Overall composite score of 8 cardinal COVID-19 related symptoms is the sum of 8 cardinal COVID-19 related symptom scores (i.e., cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat).
Time to resolution of fever Day 1 to Day 35 Resolution of fever is defined as from Day 1 until the day at which a patient's daily maximum temperature achieves and remains below 100.4 Degrees Fahrenheit for the rest of the intake period and for the follow-up period without an antipyretic medication.
Proportion of patients with decreased oxygen saturation Day 14, Day 35 Effect of COVID-19 symptoms on physical activities Day 1 to Day 35 Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.
Trial Locations
- Locations (16)
Axon Clinical Research
🇺🇸Riverside, California, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Wake Research - Clinical Research Center of Nevada, LLC
🇺🇸Las Vegas, Nevada, United States
Centex Studies
🇺🇸Houston, Texas, United States
Global Medical Research
🇺🇸DeSoto, Texas, United States
Vista Health Research
🇺🇸Miami, Florida, United States
Healthstar Research
🇺🇸Hot Springs, Arkansas, United States
M3 Wake Research, Inc
🇺🇸Raleigh, North Carolina, United States
Bio-Medical Research
🇺🇸Miami, Florida, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Carolina Institute For Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Mount Vernon Clinical Research
🇺🇸Atlanta, Georgia, United States
Infectious Diseases Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
TruCare Internal Medicine and Infectious Diseases
🇺🇸DuBois, Pennsylvania, United States
ClinSearch LLC
🇺🇸Chattanooga, Tennessee, United States
Centex Studies, Inc. - Lake Charles
🇺🇸Lake Charles, Louisiana, United States