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

Phase 2

Withdrawn

• Conditions: COVID-19 Acute Respiratory Distress Syndrome; Cytokine Release Syndrome
• Interventions: Drug: Tazemetostat

• Registration Number: NCT05018975
• Lead Sponsor: Loma Linda University

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).

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-24
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-22
• Study Start: 2022-01
• Primary Completion: 2023-09-21
• Study Completion: 2023-09-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tazemetostat	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.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	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.