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

COVID-19 Acute Respiratory Distress Syndrome Clinical Trial

— IST  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05018975
• Other study ID #: 2210094
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2022
• Est. completion date: September 21, 2023

Study information

• Verified date: August 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Cytokine Release Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Tazemetostat
Tazemetostat 800mg BID PO dosing for 15 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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