NCT05018975

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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).

Conditions

• COVID-19 Acute Respiratory Distress Syndrome
• Cytokine Release Syndrome

Interventions

Type	Name	Description
DRUG	Tazemetostat	Tazemetostat 800mg BID PO dosing for 15 days

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-09-21
• Completion: 2023-09-21
• First posted: 2021-08-24
• Last updated: 2021-11-22

Regulatory

• FDA-regulated drug study