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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name Ta1

NCTNCT04428008 (opens ClinicalTrials.gov in a new tab)Other idACW-1221958-1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
189 participants (actual)
Sponsor
William B. Ershler, MD · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
12 Jan 2021
Primary completion
19 Jan 2023
Completion
19 Jan 2023
First posted
11 Jun 2020
Last update posted
21 Apr 2026
Conditions
COVID-19

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 2

    Ta1

    NCT04428008

    12 Jan 2021 to 19 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ThymalfasinDrug

Arms2

  • Experimental

    Active arm

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

  • No intervention

    Control arm

    Standard care

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With COVID-19 Infection

    Time frame · 6 months

    Registry description

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

Secondary outcomes(3)

  1. Hospitalization

    Time frame · 6 months

    Registry description

    Number of participants who were hospitalized

  2. Non-COVID-19 Infections

    Time frame · 6 months

    Registry description

    Number of participants with non-COVID-19 infections

  3. Mortality

    Time frame · 6 months

    Registry description

    Number of subjects who died

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

Number of Participants With COVID-19 Infection

GroupValue (participants)
Active Arm5
Control Arm7
Secondary and other outcome results(3)
Secondary outcomeNumber· 6 months

Hospitalization

GroupValue (Participants)
Active Arm27
Control Arm26
Secondary outcomeNumber· 6 months

Non-COVID-19 Infections

GroupValue (participants)
Active Arm8
Control Arm6
Secondary outcomeNumber· 6 months

Mortality

GroupValue (participants)
Active Arm3
Control Arm7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Active Arm1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks3 / 9128 / 910 / 91
Control ArmStandard care7 / 9826 / 980 / 98

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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