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

Mild-to-moderate COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414124
• Other study ID #: K031-120
• Status: Completed
• Phase: N/A
• Start date: August 2, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: August 2021
• Source: Kaleido Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mild-to-moderate COVID-19

Intervention

Other:
• KB109 + Self Supportive Care (SSC)
KB109 is a novel glycan
• Self Supportive Care (SSC) Alone
Self Supportive Care (SSC) Alone

Locations

Country	Name	City	State
United States	Mount Vernon Clinical Research	Atlanta	Georgia
United States	ClinSearch LLC	Chattanooga	Tennessee
United States	Global Medical Research	DeSoto	Texas
United States	TruCare Internal Medicine and Infectious Diseases	DuBois	Pennsylvania
United States	Carolina Institute For Clinical Research	Fayetteville	North Carolina
United States	Healthstar Research	Hot Springs	Arkansas
United States	Centex Studies	Houston	Texas
United States	Centex Studies, Inc. - Lake Charles	Lake Charles	Louisiana
United States	Wake Research - Clinical Research Center of Nevada, LLC	Las Vegas	Nevada
United States	Infectious Diseases Associates of Central Virginia	Lynchburg	Virginia
United States	Bio-Medical Research	Miami	Florida
United States	Vista Health Research	Miami	Florida
United States	M3 Wake Research, Inc	Raleigh	North Carolina
United States	Axon Clinical Research	Riverside	California
United States	Medical Center for Clinical Research	San Diego	California
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Kaleido Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)		Day 1 to Day 35
Secondary	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
Secondary	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
Secondary	Proportion of patients with decreased oxygen saturation		Day 14, Day 35
Secondary	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
Secondary	Proportion of patients requiring hospitalization		Day 1 to Day 35
Secondary	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
Secondary	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