Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection (NCT05018975) | Clinical Trial Compass
WithdrawnPhase 2
Tazemetostat for the Treatment of Moderate to Severe COVID-19 Infection
Stopped: FDA recommendation cited safety issues
0Started 2022-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial was withdrawn before enrolling any participants, can you tell me whether there are other active studies looking at tazemetostat or similar EZH2 inhibitors for COVID-19-related lung complications that I might be eligible for?
2This was a Phase 2 trial, meaning researchers were still in early stages of testing tazemetostat for COVID-19 — given that it was withdrawn, what does that mean for how much is actually known about whether this approach is safe or effective for cytokine release syndrome?
3The trial was focused on reducing hospital stay length in patients with COVID-19 acute respiratory distress syndrome — are there currently approved or standard treatments for cytokine release syndrome that I should consider first, rather than waiting for an experimental option?
4Because tazemetostat is primarily an cancer drug being repurposed here, what risks would you want me to understand about using it in the context of a severe COVID-19 infection, especially since this trial never completed?
5Given that this study was withdrawn and never produced results, how would you recommend I find up-to-date clinical trials or emerging treatments for COVID-19-related ARDS and cytokine storm that are currently open and actively enrolling?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Length of hospital stay
Timeframe: Up to one year from date of randomization