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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KB109 + Self Supportive Care (SSC) | Other |
| |
| Self Supportive Care (SSC) Alone | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KB109 + Self Supportive Care (SSC) | Other | KB109 is a novel glycan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) | Day 1 to Day 35 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wingertzahn, PhD | Kaleido Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthstar Research | Hot Springs | Arkansas | 71913 | United States | ||
| Axon Clinical Research |
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| Self Supportive Care (SSC) Alone |
| Other |
Self Supportive Care (SSC) Alone |
|
| 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 |
| Riverside |
| California |
| 92505 |
| United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Vista Health Research | Miami | Florida | 33176 | United States |
| Bio-Medical Research | Miami | Florida | 33184 | United States |
| Mount Vernon Clinical Research | Atlanta | Georgia | 30328 | United States |
| Centex Studies, Inc. - Lake Charles | Lake Charles | Louisiana | 70601 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Wake Research - Clinical Research Center of Nevada, LLC | Las Vegas | Nevada | 89104 | United States |
| Carolina Institute For Clinical Research | Fayetteville | North Carolina | 28304 | United States |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | United States |
| TruCare Internal Medicine and Infectious Diseases | DuBois | Pennsylvania | 15801 | United States |
| ClinSearch LLC | Chattanooga | Tennessee | 37421 | United States |
| Global Medical Research | DeSoto | Texas | 75115 | United States |
| Centex Studies | Houston | Texas | 77058 | United States |
| Infectious Diseases Associates of Central Virginia | Lynchburg | Virginia | 24501 | United States |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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