Etoposide in Patients With COVID-19 Infection
NCT04356690 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2023-06-15
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 performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 in patients with COVID-19 infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the investigator and treating physician believe the patient had clinical benefit from etoposide therapy but subsequently has evidence of recurrent clinical deterioration. Subjects randomized to control will receive standard of care treatment. No placebo will be used.
Conditions
Interventions
- DRUG
-
Etoposide
Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4.
Sponsors & Collaborators
-
Boston Medical Center
lead OTHER
Principal Investigators
-
John Mark Sloan, MD · Boston Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-08
- Primary Completion
- 2022-07-01
- Completion
- 2022-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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