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

Study Overview
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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).

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

Conditions
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COVID-19 Acute Respiratory Distress Syndrome, Cytokine Release Syndrome

Intervention / Treatment
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* Drug: Tazemetostat


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tazemetostat<br>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<br>* Tazemetostat 800mg BID PO dosing for 15 days<br>* Other names: Tazemetostat oral tablet;|
| No Intervention: Control<br>Subjects receiving standard of care treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to one year from date of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Cytokine Release Syndrome Due to SARS-CoV-2 Disease