Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation |
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There is one clinical trial.
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 months