<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487444</url>
  </required_header>
  <id_info>
    <org_study_id>SCN-16130571-2</org_study_id>
    <nct_id>NCT04487444</nct_id>
  </id_info>
  <brief_title>Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection</brief_title>
  <acronym>Ta1</acronym>
  <official_title>A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is our hypothesis that a course of Ta1 administered to hospitalized individuals with&#xD;
      COVID-19 infection and lymphocytopenia will improve the time to recovery (primary objective)&#xD;
      and severity of infection (secondary objectives) compared to untreated individuals in the&#xD;
      same hospital with comparable lymphocytopenia.&#xD;
&#xD;
      After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the&#xD;
      inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1&#xD;
      week. Individuals in the control arm will be followed on the identical protocol but will not&#xD;
      receive daily Ta1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ta1 is a naturally occurring peptide that has been evaluated for its immunomodulatory&#xD;
      activities and related therapeutic potential in several conditions and diseases, including&#xD;
      infectious disease and cancer. ZADAXIN® brand Ta1 is a synthetic version currently approved&#xD;
      for use in 37 countries; in particular it is approved in China for treatment of hepatitis B&#xD;
      and to enhance vaccine response. Notably, Ta1 has been used clinically in pilot studies for&#xD;
      treatment of severe acute respiratory syndrome (SARS) and other lung infections including&#xD;
      acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disorder (COPD),&#xD;
      as well as infections after bone marrow transplant. Larger clinical trials have shown&#xD;
      significant efficacy for treatment of severe sepsis and hepatitis B, along with certain&#xD;
      cancers such as melanoma, hepatocellular, and lung cancer. Ta1 has also demonstrated&#xD;
      improvement in response to vaccines in the elderly and in patients immunocompromised by renal&#xD;
      disease.&#xD;
&#xD;
      Ta1 restores immune system homeostasis, by acting as multi-tasking protein depending on the&#xD;
      host state of inflammation or immune dysfunction (such as infectious disease and cancer). Ta1&#xD;
      is believed to directly enhance the immune systems' recognition of infected cells and tumors&#xD;
      cells, while also possibly modulating T cell activity and stimulating both innate and&#xD;
      adaptive immunity to clear bacteria, virus, fungi and tumor cells. Ta1 serves a unique&#xD;
      function in balancing pro-inflammatory and anti-inflammatory cytokine production through the&#xD;
      regulation of distinct Toll-like receptors (TLRs) on different dendritic cell subsets. Data&#xD;
      from other coronaviruses such as SARS-CoV and Middle Eastern respiratory syndrome (MERS)-CoV&#xD;
      indicate that infection relies on their ability to impair both innate and adaptive immunity.&#xD;
      During the 2003 pandemic, Ta1 was used as a prophylactic agent against SARS. Some published&#xD;
      reports suggest that timely administration of immune-enhancers such as Ta1 to SARS patients&#xD;
      was efficacious to a certain extent in controlling the development of the disease. Another&#xD;
      study investigated the clinical manifestations, pharmacotherapy and prognosis of 46 patients&#xD;
      with SARS and divided the severe cases (22 cases) into 2 groups according to administration&#xD;
      of Ta1 and showed that the incidence rate of pulmonary fibrosis was lower in the group with&#xD;
      Ta1 (2 of 14 cases) than the group without (6 out of 8 cases), i.e., 14.3% and 75.0%,&#xD;
      respectively.&#xD;
&#xD;
      A recent study presented a retrospective analysis of hospitalized COVID-19 patients in China,&#xD;
      in which those treated with Ta1 showed an improvement in lymphocyte subsets as well as a&#xD;
      significant reduction in mortality (from 30 to 11%, p = 0.04).&#xD;
&#xD;
      Based on post-marketing treatment experience of more than 600,000 patients, Ta1 has been well&#xD;
      tolerated. Ta1 has been administered to elderly subjects (up to 101 years old), children (as&#xD;
      young as 13 months), and immunocompromised patients. The most common adverse events (AEs) in&#xD;
      previous clinical trials include injection-site pain (such as burning and itching) which was&#xD;
      mild and lasted for less than 30 minutes, as well as fever, nausea, and flu-like symptoms&#xD;
      which were mild to moderate in severity. Thus, while Ta1 is one of only a few&#xD;
      immunomodulatory agents that have been approved for human use, it does not appear to induce&#xD;
      most of the side effects and toxicities commonly associated with other biological response&#xD;
      modifiers (BRMs) in this class, such as interferon and interleukin (IL)-2.&#xD;
&#xD;
      The primary objective of the study is to determine whether Ta1 administered daily for one&#xD;
      week to hospitalized COVID-19 patients with lymphocytopenia will improve time to recovery&#xD;
      (free of respiratory failure) compared with a similar population of patients who do not&#xD;
      receive Ta1. The secondary objectives are to determine whether hospitalized COVID-19 patients&#xD;
      with lymphocytopenia treated with Ta1 will have a milder course of infection in terms of&#xD;
      length of hospitalization stay, requirement (and length) for ICU stay, and requirement for&#xD;
      supplemental oxygen or mechanical ventilation than patients not treated with Ta1, as well as&#xD;
      higher chances of survival.&#xD;
&#xD;
      After screening, hospitalized patients with COVID-19 and lymphocytopenia who meet the&#xD;
      inclusion criteria will receive Ta1 (1.6 mg) administered subcutaneously (SC) daily for 1&#xD;
      week. Individuals in the control arm will be followed on the identical protocol but will not&#xD;
      receive daily Ta1. After the treatment period, all subjects will be followed and evaluated&#xD;
      for efficacy outcomes at Day 14, with follow-up visits at Days 28, 42, and 60 (by phone, if&#xD;
      the subject has been discharged from the hospital) to determine any AE/serious adverse event&#xD;
      (SAE) and mortality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated due to slow enrollment and the transfer of the PI to another&#xD;
    institution.&#xD;
  </why_stopped>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Actual">February 3, 2023</completion_date>
  <primary_completion_date type="Actual">February 3, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to recovery (free of respiratory failure)</measure>
    <time_frame>Day 28</time_frame>
    <description>Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lymphopenia</measure>
    <time_frame>Day 14</time_frame>
    <description>Evaluation of CD4 and CD8 levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>Day 28</time_frame>
    <description>Percentage of subjects still alive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Day 28</time_frame>
    <description>Length of time before hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirement for high flow oxygen supplementation</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of subjects that require high flow oxygen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of high flow oxygen supplementation</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of days that each subject requires high flow oxygen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU admission</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of subjects that are admitted to the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of days that each subject remains in the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of subjects that require mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of days that each subject requires the mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of subjects that have decreases or increases in comorbidities existing at time of enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.)</measure>
    <time_frame>Day 28</time_frame>
    <description>Number of subjects who get infections other than COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AEs/SAEs</measure>
    <time_frame>Day 60</time_frame>
    <description>Adverse events and serious adverse events experienced by the subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes to vital signs</measure>
    <time_frame>Day 28</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in laboratory parameters</measure>
    <time_frame>Day 28</time_frame>
    <description>Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Ta1 treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment will be provided in addition to standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thymalfasin</intervention_name>
    <description>Synthetic 28 amino acid peptide identical to naturally circulating compound</description>
    <arm_group_label>Ta1 treatment arm</arm_group_label>
    <other_name>Thymosin alpha 1</other_name>
    <other_name>ZADAXIN (brand name)</other_name>
    <other_name>Ta1 (abbreviation)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  PCR positive for COVID-19 within the last 4 days&#xD;
&#xD;
          -  Hospitalized&#xD;
&#xD;
          -  SpO2 ≤ 93% on room air or requiring supplemental oxygen at screening (i.e. patients&#xD;
             with severe disease)&#xD;
&#xD;
          -  Lymphopenia (total lymphocyte count &lt; 1.5 × 109/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on mechanical ventilation&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  Patients with multi-organ failure&#xD;
&#xD;
          -  Patients with advanced malignancy receiving cytotoxic chemotherapy&#xD;
&#xD;
          -  Patients with prior history of solid organ (kidney, liver, heart, lung, pancreas) or&#xD;
             bone marrow transplant&#xD;
&#xD;
          -  Patients on any other immunomodulatory therapy&#xD;
&#xD;
          -  Patients receiving Plaquenil&#xD;
&#xD;
          -  Patients who have participated in an investigational drug or device trial in previous&#xD;
             30 days&#xD;
&#xD;
          -  Patients with a history of allergy or intolerance to Ta1&#xD;
&#xD;
          -  Any other medical or psychiatric condition that, in the opinion of the Investigator,&#xD;
             would compromise patient safety or interfere with the objectives of the protocol or&#xD;
             completion of the protocol treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eleftherios Mylonakis, MD PhD FIDSA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lifespan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Liu Y, Pan Y, Hu Z, Wu M, Wang C, Feng Z, Mao C, Tan Y, Liu Y, Chen L, Li M, Wang G, Yuan Z, Diao B, Wu Y, Chen Y. Thymosin Alpha 1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells. Clin Infect Dis. 2020 Nov 19;71(16):2150-2157. doi: 10.1093/cid/ciaa630.</citation>
    <PMID>32442287</PMID>
  </reference>
  <results_reference>
    <citation>Shehadeh F, Benitez G, Mylona EK, Tran QL, Tsikala-Vafea M, Atalla E, Kaczynski M, Mylonakis E. A Pilot Trial of Thymalfasin (Thymosin-alpha-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection. J Infect Dis. 2023 Jan 11;227(2):226-235. doi: 10.1093/infdis/jiac362.</citation>
    <PMID>36056913</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>February 12, 2023</last_update_submitted>
  <last_update_submitted_qc>February 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>thymosin alpha 1</keyword>
  <keyword>lymphocytopenia</keyword>
  <keyword>thymalfasin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thymalfasin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487444
org study id: SCN-16130571-2
nct id: NCT04487444
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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® brand Ta1 is a synthetic version currently approved
      for use in 37 countries; in particular it is approved in China for treatment of hepatitis B
      and to enhance vaccine response. Notably, Ta1 has been used clinically in pilot studies for
      treatment of severe acute respiratory syndrome (SARS) and other lung infections including
      acute respiratory distress syndrome (ARDS) 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.

      Ta1 restores immune system homeostasis, by acting as multi-tasking protein depending on the
      host state of inflammation or immune dysfunction (such as infectious disease and cancer). Ta1
      is believed to directly enhance the immune systems' recognition of infected cells and tumors
      cells, while also possibly modulating T cell activity and stimulating both innate and
      adaptive immunity to clear bacteria, virus, fungi and tumor cells. Ta1 serves a unique
      function in balancing pro-inflammatory and anti-inflammatory cytokine production through the
      regulation of distinct Toll-like receptors (TLRs) on different dendritic cell subsets. Data
      from other coronaviruses such as SARS-CoV and Middle Eastern respiratory syndrome (MERS)-CoV
      indicate that infection relies on their ability to impair both innate and adaptive immunity.
      During the 2003 pandemic, Ta1 was used as a prophylactic agent against SARS. Some published
      reports suggest that timely administration of immune-enhancers such as Ta1 to SARS patients
      was efficacious to a certain extent in controlling the development of the disease. Another
      study investigated the clinical manifestations, pharmacotherapy and prognosis of 46 patients
      with SARS and divided the severe cases (22 cases) into 2 groups according to administration
      of Ta1 and showed that the incidence rate of pulmonary fibrosis was lower in the group with
      Ta1 (2 of 14 cases) than the group without (6 out of 8 cases), i.e., 14.3% and 75.0%,
      respectively.

      A recent study presented a retrospective analysis of hospitalized COVID-19 patients in China,
      in which those treated with Ta1 showed an improvement in lymphocyte subsets as well as a
      significant reduction in mortality (from 30 to 11%, p = 0.04).

      Based on post-marketing treatment experience of more than 600,000 patients, Ta1 has been well
      tolerated. Ta1 has been administered to elderly subjects (up to 101 years old), children (as
      young as 13 months), and immunocompromised patients. The most common adverse events (AEs) in
      previous clinical trials include injection-site pain (such as burning and itching) which was
      mild and lasted for less than 30 minutes, as well as fever, nausea, and flu-like symptoms
      which were mild to moderate in severity. Thus, while Ta1 is one of only a few
      immunomodulatory agents that have been approved for human use, it does not appear to induce
      most of the side effects and toxicities commonly associated with other biological response
      modifiers (BRMs) in this class, such as interferon and interleukin (IL)-2.

      The primary objective of the study is to determine whether Ta1 administered daily for one
      week to hospitalized COVID-19 patients with lymphocytopenia will improve time to recovery
      (free of respiratory failure) compared with a similar population of patients who do not
      receive Ta1. The secondary objectives are to determine whether hospitalized COVID-19 patients
      with lymphocytopenia treated with Ta1 will have a milder course of infection in terms of
      length of hospitalization stay, requirement (and length) for ICU stay, and requirement for
      supplemental oxygen or mechanical ventilation than patients not treated with Ta1, as well as
      higher chances of survival.

      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. After the treatment period, all subjects will be followed and evaluated
      for efficacy outcomes at Day 14, with follow-up visits at Days 28, 42, and 60 (by phone, if
      the subject has been discharged from the hospital) to determine any AE/serious adverse event
      (SAE) and mortality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to recovery (free of respiratory failure)
time frame: Day 28
description: Length of time for patient to no longer require supplemental oxygen and can sustain a good oxygen saturation (SpO2) on room air
measure: Lymphopenia
time frame: Day 14
description: Evaluation of CD4 and CD8 levels
measure: Survival
time frame: Day 28
description: Percentage of subjects still alive
measure: Hospital length of stay
time frame: Day 28
description: Length of time before hospital discharge
measure: Requirement for high flow oxygen supplementation
time frame: Day 28
description: Number of subjects that require high flow oxygen
measure: Duration of high flow oxygen supplementation
time frame: Day 28
description: Number of days that each subject requires high flow oxygen
measure: ICU admission
time frame: Day 28
description: Number of subjects that are admitted to the ICU
measure: ICU length of stay
time frame: Day 28
description: Number of days that each subject remains in the ICU
measure: Mechanical ventilation
time frame: Day 28
description: Number of subjects that require mechanical ventilation
measure: Duration of mechanical ventilation
time frame: Day 28
description: Number of days that each subject requires the mechanical ventilation
measure: Change in any existing comorbidities (e.g., worsening congestive heart failure) or occurrence of newly diagnosed disease
time frame: Day 28
description: Number of subjects that have decreases or increases in comorbidities existing at time of enrollment
measure: Incidence of non-COVID-19 infections (other respiratory, urinary tract, cellulitis, etc.)
time frame: Day 28
description: Number of subjects who get infections other than COVID-19
measure: AEs/SAEs
time frame: Day 60
description: Adverse events and serious adverse events experienced by the subjects
measure: Changes to vital signs
time frame: Day 28
description: 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
measure: Changes in laboratory parameters
time frame: Day 28
description: Mild, moderate, or severe changes to laboratory parameters (complete blood count and standard chemistry surveys) based on perceived clinical significance of the change
arm group label: Ta1 treatment arm
arm group type: Experimental
description: 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.
arm group label: Control arm
arm group type: No Intervention
description: No treatment will be provided in addition to standard of care.
intervention type: Drug
intervention name: Thymalfasin
description: Synthetic 28 amino acid peptide identical to naturally circulating compound
arm group label: Ta1 treatment arm
other name: Thymosin alpha 1
other name: ZADAXIN (brand name)
other name: Ta1 (abbreviation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eleftherios Mylonakis, MD PhD FIDSA
role: Principal Investigator
affiliation: Lifespan
facility: 
country: United States
citation: Liu Y, Pan Y, Hu Z, Wu M, Wang C, Feng Z, Mao C, Tan Y, Liu Y, Chen L, Li M, Wang G, Yuan Z, Diao B, Wu Y, Chen Y. Thymosin Alpha 1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells. Clin Infect Dis. 2020 Nov 19;71(16):2150-2157. doi: 10.1093/cid/ciaa630.
PMID: 32442287
citation: Shehadeh F, Benitez G, Mylona EK, Tran QL, Tsikala-Vafea M, Atalla E, Kaczynski M, Mylonakis E. A Pilot Trial of Thymalfasin (Thymosin-alpha-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection. J Infect Dis. 2023 Jan 11;227(2):226-235. doi: 10.1093/infdis/jiac362.
PMID: 36056913
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Thymalfasin
sharing ipd: No