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

Kaleido Biosciences350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

350

Conditions

Mild-to-moderate COVID-19

Interventions

KB109 + Self Supportive Care (SSC)OTHER

KB109 is a novel glycan

Self Supportive Care (SSC) AloneOTHER

Self Supportive Care (SSC) Alone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Healthstar Research

Hot Springs, Arkansas, United States

Axon Clinical Research

Riverside, California, United States

Outcomes

Primary Outcomes

Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)

Time frame: Day 1 to Day 35

Secondary Outcomes

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)

Time frame: 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.

Time frame: Day 1 to Day 35

Proportion of patients with decreased oxygen saturation

Time frame: 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.

Time frame: Day 1 to Day 35

Proportion of patients requiring hospitalization

Time frame: 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).

Data from ClinicalTrials.gov

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