REMDACTA trial for COVID-19 pneumonia
The purpose of this study is to compare the safety and effectiveness of treatment with remdesivir plus tocilizumab compared with remdesivir alone in subjects with COVID-19 pneumonia. In this study, patients will be randomized 2:1 to receive tocilizumab (monoclonal antibody vs Interleukin-6) or placebo. A placebo looks like a drug but does not have any active ingredient. All patients will receive remdesivir.
This research study is led by Dr. Daniel Skiest.
Contact: Lori Kozikowski, 413-794-5584
Primary Sponsor: F. Hoffmann-La Roche Ltd
June 29, 2020
Baystate Medical Center, 759 Chestnut Street, Springfield, MA
- Hospitalized with COVID-19 pneumonia confirmed by PCR and chest X-ray or CT scan.
- Requiring > 6 L/min supplemental oxygen to maintain SpO2 > 93%.
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Known hypersensitivity to remdesivir, the metabolites, or formulation excipients.
- Active TB infection.
- Suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months.
- Participating in another drug clinical trial.