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

NCT ID: NCT05018975

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-09-21

Brief Summary

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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

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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).

Conditions

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COVID-19 Acute Respiratory Distress Syndrome Cytokine Release Syndrome

Keywords

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Systemic Cytokine Release Syndrome Due to SARS-CoV-2 Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tazemetostat

Intervention Type DRUG

Tazemetostat 800mg BID PO dosing for 15 days

Control

Subjects receiving standard of care treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tazemetostat

Tazemetostat 800mg BID PO dosing for 15 days

Intervention Type DRUG

Other Intervention Names

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Tazemetostat oral tablet

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ciprian P Gheorghe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Other Identifiers

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2210094

Identifier Type: -

Identifier Source: org_study_id