Status:
TERMINATED
Etoposide in Patients With COVID-19 Infection
Lead Sponsor:
Boston Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label phase II study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization will be perfor...
Detailed Description
The rationale for the use of etoposide to treat the cytokine storm in COVID-19 is the high mortality associated with the hyperinflammatory response to the virus, which is similar to that seen in other...
Eligibility Criteria
Inclusion
- Confirmed COVID-19 infection
- Evidence of cytokine storm defined as:
- Peak ferritin \> 10,000 ng/mL OR
- Peak ferritin \> 500 ng/mL and one or more of the following at any time during hospital admission: Lactate dehydrogenase \> 500 U/L, d-dimer \>1000 ng/mL, C-reactive protein \> 100 mg/L, or white blood count\> 15 k/microlitre
- Cohort 1: Intubated status as a result of COVID infection-associated respiratory illness.
Exclusion
- Pregnancy or breastfeeding
- History of severe hypersensitivity to etoposide products
- Absolute neutrophil count (ANC) \< 1000 cells/mm3
- Platelet count \<50,000/mm3
- Bilirubin \> 3.0 mg/dL
- Aspartate OR alanine aminotransferase \> 5.0 x upper limit of normal
- Creatinine Clearance \< 15 mL/min (calculated by Cockcroft Fault formula)
- Requiring continuous renal replacement therapy
- Requiring \>1 vasopressor
- Requiring extracorporeal membrane oxygenation (ECMO)
- Other active, life-threatening infections
- Anti-cytokine treatment (including anakinra or Interleukin 6 antibodies eg tocilizumab, sarilumab) administration within three half-lives of the medication used
- Hydroxychloroquine, colchicine, azithromycin, doxycycline-if administered for COVID infection-must be discontinued for at least 24 hours prior to randomization.
- Has a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with subject participation, or is not in the best interest of the patient to participate, in the opinion of the investigator.
- Inability to consent and no legally authorized representative
- Poorly controlled HIV infection (CD4 count \<100 cells/mm3)
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04356690
Start Date
May 8 2020
End Date
July 1 2022
Last Update
June 15 2023
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118