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Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection (Ta1)

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ClinicalTrials.gov Identifier: NCT04487444
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:

It is our hypothesis that a course of Ta1 administered to hospitalized individuals with COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective) and severity of infection (secondary objectives) compared to untreated individuals in the same hospital with comparable lymphocytopenia.

After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1 week. Individuals in the control arm will be followed on the identical protocol but will not receive daily Ta1.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Thymalfasin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Ta1 treatment arm
Ta1 at a dose of 1.6 mg will be administered SC in 1 mL of diluent daily for a total of 1 week, in addition to standard of care.
Drug: Thymalfasin
Synthetic 28 amino acid peptide identical to naturally circulating compound
Other Names:
  • Thymosin alpha 1
  • ZADAXIN (brand name)
  • Ta1 (abbreviation)

No Intervention: Control arm
No treatment will be provided in addition to standard of care.



Primary Outcome Measures :
  1. Time to recovery (free of respiratory failure) [ Time Frame: Day 28 ]
    Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air


Secondary Outcome Measures :
  1. Lymphopenia [ Time Frame: Day 14 ]
    Evaluation of CD4 and CD8 levels

  2. Survival [ Time Frame: Day 28 ]
    Percentage of subjects still alive

  3. Hospital length of stay [ Time Frame: Day 28 ]
    Length of time before hospital discharge

  4. Requirement for high flow oxygen supplementation [ Time Frame: Day 28 ]
    Number of subjects that require high flow oxygen

  5. Duration of high flow oxygen supplementation [ Time Frame: Day 28 ]
    Number of days that each subject requires high flow oxygen

  6. ICU admission [ Time Frame: Day 28 ]
    Number of subjects that are admitted to the ICU

  7. ICU length of stay [ Time Frame: Day 28 ]
    Number of days that each subject remains in the ICU

  8. Mechanical ventilation [ Time Frame: Day 28 ]
    Number of subjects that require mechanical ventilation

  9. Duration of mechanical ventilation [ Time Frame: Day 28 ]
    Number of days that each subject requires the mechanical ventilation

  10. Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease [ Time Frame: Day 28 ]
    Number of subjects that have decreases or increases in comorbidities existing at time of enrollment

  11. Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.) [ Time Frame: Day 28 ]
    Number of subjects who get infections other than COVID-19

  12. AEs/SAEs [ Time Frame: Day 60 ]
    Adverse events and serious adverse events experienced by the subjects

  13. Changes to vital signs [ Time Frame: Day 28 ]
    Mild, moderate, or severe changes to vital signs (heart rate, blood pressure, temperature, number of respirations per minute) based on perceived clinical significance of the change

  14. Changes in laboratory parameters [ Time Frame: Day 28 ]
    Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • PCR positive for COVID-19 within the last 4 days
  • Hospitalized
  • SpO2 ≤ 93% on room air or requiring supplemental oxygen at screening (i.e. patients with severe disease)
  • Lymphopenia (total lymphocyte count < 1.5 × 109/L)

Exclusion Criteria:

  • Patients on mechanical ventilation
  • Patients who are pregnant or breastfeeding
  • Patients with multi-organ failure
  • Patients with advanced malignancy receiving cytotoxic chemotherapy
  • Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or bone marrow transplant
  • Patients on any other immunomodulatory therapy
  • Patients receiving Plaquenil
  • Patients who have participated in an investigational drug or device trial in previous 30 days
  • Patients with a 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): NCT04487444


Contacts
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Contact: Eleftherios Mylonakis, MD PhD FIDSA 401-444-7856 emylonakis@lifespan.org
Contact: Fadi Shehadeh 401-444-4969 fadi_shehadeh@brown.edu

Locations
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United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Rhode Island Hospital
Investigators
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Principal Investigator: Eleftherios Mylonakis, MD PhD FIDSA Lifespan
Publications:
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT04487444    
Other Study ID Numbers: SCN-16130571-2
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhode Island Hospital:
thymosin alpha 1
lymphocytopenia
thymalfasin
Additional relevant MeSH terms:
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Infection
Thymalfasin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs