Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Inova Health System
Collaborators:
Clinical Research Consultants, LLC Davita Clinical Research Nephrology Associates of Northern Virginia, Inc.