Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thymosin Alpha 1 to Prevent COVID-19 Infection in Elderly Renal Dialysis Patients (Ta1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428008
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborators:
Nephrology Associates of Northern Virginia, Inc.
Davita Clinical Research
Information provided by (Responsible Party):
William B. Ershler, MD, Inova Health System

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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Thymalfasin Phase 2

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 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.

Thymalfasin (thymosin alpha 1, Ta1) is a naturally occurring peptide that has been evaluated for its immunomodulatory activities and related therapeutic potential in several conditions and diseases, including infectious disease and cancer. ZADAXIN, a synthetic form of Ta1, been has been used clinically in pilot studies for treatment of severe acute respiratory syndrome (SARS) and other lung infections including acute respiratory distress syndromeARDS) and chronic obstructive pulmonary disorder (COPD), as well as infections after bone marrow transplant]. Larger clinical trials have shown significant efficacy for treatment of severe sepsis and hepatitis B, along with certain cancers such as melanoma, hepatocellular, and lung cancer. Ta1 has also demonstrated improvement in response to vaccines in the elderly and in patients immunocompromised by renal disease. The beneficial clinical effects of Ta1 result from activation of toll-like receptor (TLR) 9 in dendritic and other immune system cells, resulting in augmentation of T helper (Th1) function, natural killer (NK) cell activity, and increased antibody responses to T-cell dependent antigens. Importantly, Ta1 also leads to an increase in IL-10 producing regulatory T cells, which create feedback inhibition of cytokine production, hence dampening immune response and preventing a pro-inflammatory cytokine storm.

It is our hypothesis that a course of Ta1 administered to individuals at high risk for COVID-19 infection (hemodialysis patients 60 years and older) will reduce the rate of COVID-19 infection and severity of infection with COVID-19, compared to untreated individuals in the same hemodialysis units with comparable risk. The study will also evaluate the need for hospitalization in those patients who do not become infected with COVID-19.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be centrally randomized to receive either study treatment drug (Ta1) or no Ta1. Randomization will be stratified by site.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Trial of Thymalfasin (Ta1) to Prevent COVID-19 Infection in Elderly Renal Dialysis Patients
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Active arm
1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks
Drug: Thymalfasin
Synthetic 28 amino acid peptide
Other Names:
  • Thymosin alpha 1
  • Ta1
  • ZADAXIN

No Intervention: Control arm
Standard care



Primary Outcome Measures :
  1. Reduction in documented infection with COVID-19 Reduction in infection with COVID-19 [ Time Frame: 6 months ]
    Number of subjects who become infected with COVID-19 over the course of the study


Secondary Outcome Measures :
  1. Need for hospitalization [ Time Frame: 6 months ]
    Number of subjects who become hospitalized

  2. Hospital length of stay [ Time Frame: 6 months ]
    If subject becomes hospitalized, what length of time does the subject remain hospitalized

  3. Need for ICU admission [ Time Frame: 6 months ]
    Number of subjects who are entered into the ICU

  4. ICU length of stay [ Time Frame: 6 months ]
    If subject is entered into the ICU, what length of time does the subject remain in the ICU

  5. Need for mechanical ventilation [ Time Frame: 6 months ]
    Number of subjects who require mechanical ventilation

  6. Duration of mechanical ventilation [ Time Frame: 6 months ]
    If mechanical ventilation is required, what length of time the ventilation is required

  7. Recovery time from COVID-19 [ Time Frame: 6 months ]
    If subject becomes infected with COVID-19, how long does the subject require to recover from the infection

  8. Change in any existing comorbidities or occurrence of newly diagnosed disease [ Time Frame: 6 months ]
    Evaluation of whether any comorbidities are changed over the course of treatment (eg., worsening of congestive heart failure)

  9. Incidence of non-COVID-19 infections [ Time Frame: 6 months ]
    Determination of whether there are more or fewer infections other than COVID-19 (other respiratory, urinary tract, cellulitis, etc.)

  10. Change in lymphocyte subsets (CD4, CD8) [ Time Frame: 6 months ]
    Evaluation of the levels of CD4 and CD8 subjects

  11. Mortality [ Time Frame: 6 months ]
    Number of subjects who die during the course of the study

  12. Treatment-emergent adverse events [ Time Frame: 6 months ]
    Number of subjects with mild, moderate, or severe adverse events based on perceived clinical significance of the event

  13. Treatment-emergent changes in vital signs [ Time Frame: 6 months ]
    Number of subjects with mild, moderate, or severe changes to vital signs based on perceived clinical significance of the event

  14. Treatment-emergent laboratory parameters [ Time Frame: 6 months ]
    Number of subjects with mild, moderate, or severe laboratory findings based on perceived clinical significance of the event



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 60 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428008


Contacts
Layout table for location contacts
Contact: William B Ershler, MD 571-472-1069 william.ershler@inova.org

Sponsors and Collaborators
Inova Health System
Nephrology Associates of Northern Virginia, Inc.
Davita Clinical Research
Layout table for additonal information
Responsible Party: William B. Ershler, MD, Director, Benign Hematology, Inova Health System
ClinicalTrials.gov Identifier: NCT04428008    
Other Study ID Numbers: ACW-1221958-1
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William B. Ershler, MD, Inova Health System:
COVID-19
Thymalfasin
Thymosin alpha 1
ZADAXIN
Hemodialysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Thymalfasin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs