CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Self Supportive Care (SSC) AloneWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug1516 KB109 + Self Supportive Care (SSC) Wiki 1.00
drug2805 TAK-981 Wiki 0.71
drug740 Control Wiki 0.25
drug3085 Vitamin C Wiki 0.20
drug2707 Standard of care Wiki 0.16

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D019337 Hematologic Neoplasms NIH 0.27
D009369 Neoplasms, NIH 0.15
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0001909 Leukemia HPO 0.21
HP:0002664 Neoplasm HPO 0.15

There are 2 clinical trials

Clinical Trials

1 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

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.

NCT04414124 Mild-to-moderate COVID-19 Other: KB109 + Self Supportive Care (SSC) Other: Self Supportive Care (SSC) Alone

Primary Outcomes

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

Time: Day 1 to Day 35

Secondary Outcomes

Description: 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)

Measure: Change from baseline to end of intake in overall composite COVID-19 symptom score

Time: Day 1 to Day 14

Description: 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.

Measure: Time to resolution of fever

Time: Day 1 to Day 35

Measure: Proportion of patients with decreased oxygen saturation

Time: Day 14, Day 35

Description: Effect of COVID-19 symptoms on physical activities rated as: not at all, very little, somewhat, quite a lot, could not do physical activities.

Measure: Effect of COVID-19 symptoms on physical activities

Time: Day 1 to Day 35

Measure: Proportion of patients requiring hospitalization

Time: Day 1 to Day 35

2 An Exploratory, Open Label, Clinical Study to Evaluate the Physiologic Effects of KB109 in Adult Patients With Mild-to-Moderate COVID-19 on Gut Microbiota Structure and Function in the Outpatient Setting

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.

NCT04486482 Mild-to-Moderate COVID-19 Other: KB109 + Self Supportive Care (SSC) Other: Self Supportive Care (SSC) Alone

Primary Outcomes

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

Time: Day 1 to Day 35

Secondary Outcomes

Description: Change from baseline in relative abundance of microbial taxa (operational taxanomic units) in the KB109 + SSC group versus SSC alone

Measure: Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing.

Time: Day 1 to Day 35

No related HPO nodes (Using clinical trials)