COVID-19 Acute Respiratory Distress Syndrome, Cytokine Release Syndrome
Conditions
Keywords
Systemic Cytokine Release Syndrome Due to SARS-CoV-2 Disease
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.
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).
Interventions
DRUGTazemetostat
Tazemetostat 800mg BID PO dosing for 15 days
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed