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

NCT05018975 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2210094
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Cytokine Release Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tazemetostat

EXPERIMENTAL

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

Control

NO INTERVENTION

Subjects receiving standard of care treatment

Interventions

Tazemetostat DRUG

Tazemetostat 800mg BID PO dosing for 15 days

Also known as: Tazemetostat oral tablet

Tazemetostat

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

MeSH Terms

Conditions

Cytokine Release Syndrome

Interventions

tazemetostat

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Ciprian P Gheorghe, MD, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 24, 2021
• Study Start: January 1, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: November 22, 2021

Record last verified: 2021-08