Mild-to-moderate COVID-19
Conditions
Keywords
Microbiome, COVID-19, Corona Virus, Corona Virus Disease, Kaleido, Kaleido Biosciences, KB109, Oligosaccharide, Glycan, Pathogens, Microbiome metabolic therapy, MMT, Supportive Self Care, SSC, Telemedicine
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.
Interventions
KB109 is a novel glycan
Self Supportive Care (SSC) Alone
Sponsors
Kaleido Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) | Day 1 to Day 35 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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). |
| Proportion of patients requiring hospitalization | Day 1 to Day 35 | — |
Countries
United States
Outcome results
None listed