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

NCT04428008 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ACW-1221958-1
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID-19

Keywords

COVID-19; Thymalfasin; Thymosin alpha 1; ZADAXIN; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With COVID-19 Infection

  Number of subjects who become infected with COVID-19 over the course of the study

  6 months

Secondary Outcomes (3)

• Hospitalization

  6 months

• Non-COVID-19 Infections

  6 months

• Mortality

  6 months

Study Arms (2)

Active arm

EXPERIMENTAL

1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks

Drug: Thymalfasin

Control arm

NO INTERVENTION

Standard care

Interventions

Thymalfasin DRUG

Synthetic 28 amino acid peptide

Also known as: Thymosin alpha 1, Ta1, ZADAXIN

Active arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• William B. Ershler, MD: lead
• Davita Clinical Research: collaborator

Study Sites (1)

Clinical Research Consultants

Kansas City, Kansas, 64111, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Thymalfasin; Trace amine-associated receptor 1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Limitations and Caveats

The research plan was developed during the early stages of the COVID pandemic and the goal was to see if twice weekly Thymosin would reduce infection rate in frail, elderly dialysis patients - individuals considered at high risk for infection and associated mortality. One method of determining infection was going to be sero-conversion. However, with the introduction of vaccine and its rapid application among subject participants, this made detection by this technique unreliable.

Results Point of Contact

• Title: William B. Ershler, MD
• Organization: William B. Ershler, MD Consulting

wbe2009@gmail.com

2024214426

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hematology Consultant (Private)

Model Details: Subjects will be centrally randomized to receive either study treatment drug (Ta1) or no Ta1. Randomization will be stratified by site.

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: January 12, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)