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This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.
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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 |
|---|---|---|
| Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing. | Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone | Day 1 to Day 35 |
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To be considered for enrollment into this study, each patient must meet all of the following Inclusion Criteria:
Patients who meet any of the following Exclusion Criteria at the Randomization Visit will not be enrolled into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wingertzahn, PhD | Kaleido Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cullman Clinical Trials | Cullman | Alabama | 35055 | United States | ||
| American Institute of Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33810796 | Derived | Haran JP, Pinero JC, Zheng Y, Palma NA, Wingertzahn M. Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study. Trials. 2021 Apr 2;22(1):245. doi: 10.1186/s13063-021-05157-0. |
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| Self Supportive Care (SSC) Alone |
| Other |
Self Supportive Care (SSC) Alone |
|
| Los Angeles |
| California |
| 90017 |
| United States |
| Rancho Cucamonga Clinical Research | Rancho Cucamonga | California | 91730 | United States |
| Next Phase Research Alliance | Boca Raton | Florida | 33166 | United States |
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | United States |
| Hope Clinical Trials | Miami | Florida | 33165 | United States |
| Kendall South Medical Center, Inc. | Miami | Florida | 33185 | United States |
| Quad Clinical Research | Chicago | Illinois | 60605 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Inquest Research | Baytown | Texas | 77521 | United States |
| Olympus Family Medicine | Salt Lake City | Utah | 84117 | United States |
| South Ogden Family Medicine Center | South Ogden | Utah | 84405 | 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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