Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
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| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 2 clinical trials
Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland. Ta1 is a biological response modifier which activates various cells of the immune system, and is therefore expected to have clinical benefits in disorders where immune responses are impaired or ineffective, including acute and chronic viral and bacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stage renal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of comorbidities, also have increased risk of exposure to communicable diseases as they are treated several times each week at hemodialysis centers with several other patients and clinic staff in attendance. The majority of patients are over 60 years of age and many are receiving immunosuppressive medications. Accordingly, ESRD patients are particularly susceptible to COVID-19 infection. Ta1 has been shown to be safely administered to hemodialysis patients. It is our hypothesis that a course of Ta1 administered to individuals with ESRD will reduce the rate and severity of infection with COVID-19.
Description: Number of subjects who become infected with COVID-19 over the course of the study
Measure: Reduction in documented infection with COVID-19 Reduction in infection with COVID-19 Time: 6 monthsDescription: Number of subjects who become hospitalized
Measure: Need for hospitalization Time: 6 monthsDescription: If subject becomes hospitalized, what length of time does the subject remain hospitalized
Measure: Hospital length of stay Time: 6 monthsDescription: Number of subjects who are entered into the ICU
Measure: Need for ICU admission Time: 6 monthsDescription: If subject is entered into the ICU, what length of time does the subject remain in the ICU
Measure: ICU length of stay Time: 6 monthsDescription: Number of subjects who require mechanical ventilation
Measure: Need for mechanical ventilation Time: 6 monthsDescription: If mechanical ventilation is required, what length of time the ventilation is required
Measure: Duration of mechanical ventilation Time: 6 monthsDescription: If subject becomes infected with COVID-19, how long does the subject require to recover from the infection
Measure: Recovery time from COVID-19 Time: 6 monthsDescription: Evaluation of whether any comorbidities are changed over the course of treatment (eg., worsening of congestive heart failure)
Measure: Change in any existing comorbidities or occurrence of newly diagnosed disease Time: 6 monthsDescription: Determination of whether there are more or fewer infections other than COVID-19 (other respiratory, urinary tract, cellulitis, etc.)
Measure: Incidence of non-COVID-19 infections Time: 6 monthsDescription: Evaluation of the levels of CD4 and CD8 subjects
Measure: Change in lymphocyte subsets (CD4, CD8) Time: 6 monthsDescription: Number of subjects who die during the course of the study
Measure: Mortality Time: 6 monthsDescription: Number of subjects with mild, moderate, or severe adverse events based on perceived clinical significance of the event
Measure: Treatment-emergent adverse events Time: 6 monthsDescription: Number of subjects with mild, moderate, or severe changes to vital signs based on perceived clinical significance of the event
Measure: Treatment-emergent changes in vital signs Time: 6 monthsDescription: Number of subjects with mild, moderate, or severe laboratory findings based on perceived clinical significance of the event
Measure: Treatment-emergent laboratory parameters Time: 6 monthsIt is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia. After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.
Description: Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air
Measure: Time to recovery (free of respiratory failure) Time: Day 28Description: Evaluation of CD4 and CD8 levels
Measure: Lymphopenia Time: Day 14Description: Percentage of subjects still alive
Measure: Survival Time: Day 28Description: Length of time before hospital discharge
Measure: Hospital length of stay Time: Day 28Description: Number of subjects that require high flow oxygen
Measure: Requirement for high flow oxygen supplementation Time: Day 28Description: Number of days that each subject requires high flow oxygen
Measure: Duration of high flow oxygen supplementation Time: Day 28Description: Number of subjects that are admitted to the ICU
Measure: ICU admission Time: Day 28Description: Number of days that each subject remains in the ICU
Measure: ICU length of stay Time: Day 28Description: Number of subjects that require mechanical ventilation
Measure: Mechanical ventilation Time: Day 28Description: Number of days that each subject requires the mechanical ventilation
Measure: Duration of mechanical ventilation Time: Day 28Description: Number of subjects that have decreases or increases in comorbidities existing at time of enrollment
Measure: Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease Time: Day 28Description: Number of subjects who get infections other than COVID-19
Measure: Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.) Time: Day 28Description: Adverse events and serious adverse events experienced by the subjects
Measure: AEs/SAEs Time: Day 60Description: Mild, moderate, or severe changes to vital signs (heart rate, blood pressure, temperature, number of respirations per minute) based on perceived clinical significance of the change
Measure: Changes to vital signs Time: Day 28Description: Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change
Measure: Changes in laboratory parameters Time: Day 28Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports