Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inova Health System
• Collaborators: Clinical Research Consultants, LLC; Davita Clinical Research; Nephrology Associates of Northern Virginia, Inc.
• Treatments: Thymalfasin

Criteria

Inclusion Criteria:

• Age 18 or greater

• Signed informed consent

• End-stage renal disease (ESRD) who receive hemodialysis 2 or more times each week and are expected to continue on dialysis indefinitely.

Exclusion Criteria:

• Patients on short-term hemodialysis, such as those with transient renal dysfunction associated with acute illness who are projected to have return in renal function

• Patients for whom renal transplantation is anticipated within the next six months

• Patients with an anticipated survival of less than 3 months

• Patients with symptoms that might be attributable to COVID-19 infection

• Patients who test positive for SARS-CoV2

• Patients with active infectious disease requiring antibiotics

• Patients with hospitalization within the previous 3 months for acute myocardial infarction or congestive heart failure

• Patients with advanced malignancy receiving cytotoxic chemotherapy

• Patients with a Karnofsky Performance Scale score of less than 60

• Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or bone marrow transplant

• Patients with active autoimmune disease on immunosuppressive medication

• Patients receiving Plaquenil

• Participation in an investigational drug or device trial in previous 30 days

• History of allergy or intolerance to Ta1

• Any other medical or psychiatric condition that, in the opinion of the Investigator, would compromise patient safety or interfere with the objectives of the protocol or completion of the protocol treatment