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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19

Conditions
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Mild-to-moderate COVID-19

Intervention / Treatment
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* Other: KB109 + Self Supportive Care (SSC)
* Other: Self Supportive Care (SSC) Alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: KB109 + Self Supportive Care (SSC)<br> | Other: KB109 + Self Supportive Care (SSC)<br>* KB109 is a novel glycan<br>|
| Other: Self Supportive Care (SSC) Alone<br> | Other: Self Supportive Care (SSC) Alone<br>* Self Supportive Care (SSC) Alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) |  | Day 1 to Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to end of intake in overall composite COVID-19 symptom score | 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) | Day 1 to Day 35 | 
| Time to resolution of fever | 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. | Day 1 to Day 35 | 
| Proportion of patients with decreased oxygen saturation |  | Day 14, Day 35 | 
| Effect of COVID-19 symptoms on physical activities | Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities. | Day 1 to Day 35 | 
| Proportion of patients requiring hospitalization |  | Day 1 to Day 35 | 
| Time to resolution of overall 13 COVID-19 related symptoms. | 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). | Day 1 to Day 35 | 
| Time to resolution of overall 8 cardinal COVID-19 related symptoms. | 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). | Day 1 to Day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Supportive Self Care, SSC, Telemedicine