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Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection (IST)

Primary Purpose

COVID-19 Acute Respiratory Distress Syndrome, Cytokine Release Syndrome

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tazemetostat
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Acute Respiratory Distress Syndrome focused on measuring Systemic Cytokine Release Syndrome Due to SARS-CoV-2 Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged 18-85
  • Diagnosed with q-PCR confirmed infection with SARS-Cov-2 virus and admitted to the hospital.
  • Receiving non-invasive respiratory support through a nasal cannula or a face mask.
  • Ability to take oral medication and be willing to adhere to the tazemetostat regimen.

Exclusion Criteria:

  • Unable to take PO medication.
  • Need for intubation or ECMO.
  • Pregnancy or lactation
  • Known allergic reactions to tazemetostat.
  • Active malignancy (not in remission).
  • Treatment with another investigational drug.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Tazemetostat

    Control

    Arm Description

    Subjects will receive tazemetostat 800mg BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days.

    Subjects receiving standard of care treatment

    Outcomes

    Primary Outcome Measures

    Length of hospital stay
    Evaluate the effect of tazemetostat treatment of the course of COVID-19 disease by measuring number of days in hospital from time of randomization to date of discharge or in-hospital death from any cause, whichever came first.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2021
    Last Updated
    November 17, 2021
    Sponsor
    Loma Linda University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05018975
    Brief Title
    Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection
    Acronym
    IST
    Official Title
    Repurposing Tazemetostat for the Treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    FDA recommendation cited safety issues
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    September 21, 2023 (Anticipated)
    Study Completion Date
    September 21, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Loma Linda University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and efficacy of repurposing tazemetostat for the treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 patients.
    Detailed Description
    The investigators hypothesize that tazemetostat will mitigate the hyperinflammatory effects of COVID-19 infection, prevent respiratory deterioration, and reduce requirements of invasive ventilation. This will be conducted as a Phase II open label study. After being informed about the study and potential risks, all patients giving written informed consent will undergo randomization to receive 800 mg tazemetostat BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days, additionally the patients will be evaluated at 30 and 90 days for overall clinical status and sequelae. The study will be conducted at a single site (Loma Linda University Medical Center).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19 Acute Respiratory Distress Syndrome, Cytokine Release Syndrome
    Keywords
    Systemic Cytokine Release Syndrome Due to SARS-CoV-2 Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tazemetostat
    Arm Type
    Experimental
    Arm Description
    Subjects will receive tazemetostat 800mg BID for 15 days in addition to standard of care treatment. The duration of the interventional part of the study will last 15 days.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Subjects receiving standard of care treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Tazemetostat
    Other Intervention Name(s)
    Tazemetostat oral tablet
    Intervention Description
    Tazemetostat 800mg BID PO dosing for 15 days
    Primary Outcome Measure Information:
    Title
    Length of hospital stay
    Description
    Evaluate the effect of tazemetostat treatment of the course of COVID-19 disease by measuring number of days in hospital from time of randomization to date of discharge or in-hospital death from any cause, whichever came first.
    Time Frame
    Up to one year from date of randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, aged 18-85 Diagnosed with q-PCR confirmed infection with SARS-Cov-2 virus and admitted to the hospital. Receiving non-invasive respiratory support through a nasal cannula or a face mask. Ability to take oral medication and be willing to adhere to the tazemetostat regimen. Exclusion Criteria: Unable to take PO medication. Need for intubation or ECMO. Pregnancy or lactation Known allergic reactions to tazemetostat. Active malignancy (not in remission). Treatment with another investigational drug.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ciprian P Gheorghe, MD, PhD
    Organizational Affiliation
    Loma Linda University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection

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