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

November 17, 2021 updated by: Loma Linda University

Repurposing Tazemetostat for the Treatment of Acute Respiratory Distress Syndrome (ARDS) or Systemic Cytokine Release Syndrome (SCRS) in COVID-19 Patient

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tazemetostat
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.
Drug: Tazemetostat
Tazemetostat 800mg BID PO dosing for 15 days
Other Names:
  • Tazemetostat oral tablet
No Intervention: Control
Subjects receiving standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Up to one year from date of randomization
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.
Up to one year from date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Ciprian P Gheorghe, MD, PhD, Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

September 21, 2023

Study Completion (Anticipated)

September 21, 2023

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2210094

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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