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

Sponsor

Loma Linda University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05018975

Collaborator

(none)

Enrollment

Arms

20.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome Cytokine Release Syndrome	Drug: Tazemetostat	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Sep 21, 2023

Anticipated Study Completion Date :

Sep 21, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.