Status:
COMPLETED
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
Lead Sponsor:
William B. Ershler, MD
Collaborating Sponsors:
Davita Clinical Research
Ahmed Awad, MD
Conditions:
COVID-19
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2023
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04428008
Start Date
January 12 2021
End Date
January 19 2023
Last Update
October 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Consultants
Kansas City, Kansas, United States, 64111