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
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ClinicalTrials.gov Identifier: NCT04414124 |
Recruitment Status :
Completed
First Posted : June 4, 2020
Last Update Posted : August 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild-to-moderate COVID-19 | Other: KB109 + Self Supportive Care (SSC) Other: Self Supportive Care (SSC) Alone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | August 2, 2020 |
Actual Primary Completion Date : | February 2, 2021 |
Actual Study Completion Date : | February 2, 2021 |

Arm | Intervention/treatment |
---|---|
KB109 + Self Supportive Care (SSC) |
Other: KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan |
Self Supportive Care (SSC) Alone |
Other: Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone |
- Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 35 ]
- Change from baseline to end of intake in overall composite COVID-19 symptom score [ Time Frame: 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 fever [ Time Frame: 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 [ Time Frame: Day 14, Day 35 ]
- Effect of COVID-19 symptoms on physical activities [ Time Frame: 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.
- Proportion of patients requiring hospitalization [ Time Frame: Day 1 to Day 35 ]
- Time to resolution of overall 13 COVID-19 related symptoms. [ Time Frame: 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. [ Time Frame: 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414124
United States, Arkansas | |
Healthstar Research | |
Hot Springs, Arkansas, United States, 71913 | |
United States, California | |
Axon Clinical Research | |
Riverside, California, United States, 92505 | |
Medical Center for Clinical Research | |
San Diego, California, United States, 92108 | |
United States, Florida | |
Vista Health Research | |
Miami, Florida, United States, 33176 | |
Bio-Medical Research | |
Miami, Florida, United States, 33184 | |
United States, Georgia | |
Mount Vernon Clinical Research | |
Atlanta, Georgia, United States, 30328 | |
United States, Louisiana | |
Centex Studies, Inc. - Lake Charles | |
Lake Charles, Louisiana, United States, 70601 | |
United States, Massachusetts | |
University of Massachusetts Medical School | |
Worcester, Massachusetts, United States, 01655 | |
United States, Nevada | |
Wake Research - Clinical Research Center of Nevada, LLC | |
Las Vegas, Nevada, United States, 89104 | |
United States, North Carolina | |
Carolina Institute For Clinical Research | |
Fayetteville, North Carolina, United States, 28304 | |
M3 Wake Research, Inc | |
Raleigh, North Carolina, United States, 27612 | |
United States, Pennsylvania | |
TruCare Internal Medicine and Infectious Diseases | |
DuBois, Pennsylvania, United States, 15801 | |
United States, Tennessee | |
ClinSearch LLC | |
Chattanooga, Tennessee, United States, 37421 | |
United States, Texas | |
Global Medical Research | |
DeSoto, Texas, United States, 75115 | |
Centex Studies | |
Houston, Texas, United States, 77058 | |
United States, Virginia | |
Infectious Diseases Associates of Central Virginia | |
Lynchburg, Virginia, United States, 24501 |
Study Director: | Mark Wingertzahn, PhD | Kaleido Biosciences |
Responsible Party: | Kaleido Biosciences |
ClinicalTrials.gov Identifier: | NCT04414124 |
Other Study ID Numbers: |
K031-120 |
First Posted: | June 4, 2020 Key Record Dates |
Last Update Posted: | August 13, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Microbiome COVID-19 Corona Virus Corona Virus Disease Kaleido Kaleido Biosciences KB109 Oligosaccharide |
Glycan Pathogens Microbiome metabolic therapy MMT Supportive Self Care SSC Telemedicine |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |