REMDACTA Clinical Trial
Hospitalized with COVID-19 pneumonia which has been confirmed by both:
- PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid). The PCR test must have been collected <= 7 days before randomization
- Chest X-ray or CT scan
Eligible patients would also be receiving > 6 L/min supplemental oxygen to maintain SpO2 >93%.
The key exclusion criteria for the study are as follows:
- Aged below 12 years
- Participation in another clinical trial for the treatment of COVID-19 while participating in this study
- Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
- Prior or current treatment with remdesivir for COVID-19
- Known severe allergic reactions to tocilizumab or other monoclonal antibodies
- Known hypersensitivity to remdesivir
- Active TB infection/suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
- Estimated glomerular filtration rate (eGFR) < 30 mL/min
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours
Boston Medical Center is participating in a global phase III, randomised, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra (tocilizumab) plus the antiviral remdesivir versus remdesivir plus placebo in hospitalized patients with severe COVID-19 pneumonia.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables. Participants will be followed for 60 days post-randomization. While hospitalized, clinical information will be collected such as vital signs and physical exams along with blood samples and nasal swabs. After discharge, participants will be asked to come back to the hospital 1-2 times for follow-up.