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NCT Number: NCT04414124

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

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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Key information

Conditions

Mild-to-moderate COVID-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthstar Research, Hot Springs, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KB109 + Self Supportive Care (SSC)

Other

KB109 is a novel glycan

Self Supportive Care (SSC) Alone

Other

Self Supportive Care (SSC) Alone

Primary outcomes

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

    Time frame: Day 1 to Day 35

Secondary outcomes

  1. 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)

  2. 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.

  3. Proportion of patients with decreased oxygen saturation

    Time frame: Day 14, Day 35

  4. 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.

  5. Proportion of patients requiring hospitalization

    Time frame: Day 1 to Day 35

  6. 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).

  7. 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).

Sponsors and collaborators

Lead sponsor

Kaleido Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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