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A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia

NCT04409262

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: COVID-19 Pneumonia

Interventions: Remdesivir, Tocilizumab, Placebo

Countries: United States, Brazil, Russia, Spain

This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

* Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
* Requiring more than 6 L/min supplemental oxygen to maintain SpO2 \> 93%
* Agrees to not participate in another clinical trial for the treatment of COVID-19 while participating in this study

Exclusion Criteria

* Known severe allergic reactions to tocilizumab or other monoclonal antibodies
* Known hypersensitivity to remdesivir, the metabolites, or formulation excipients
* Active tuberculosis (TB) infection
* Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
* Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 within 24 hours prior to study drug dosing. In addition, participants with prior or current treatment with \> 2 doses of remdesivir for COVID-19 are excluded
* Participating in other drug clinical trials
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min (including patients receiving hemodialysis or hemofiltration)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges)
* Absolute neutrophil count (ANC) \< 1000/uL at screening
* Platelet count \< 50,000/uL at screening
* Body weight \< 40 kg
* Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization

Locations (54)

Phoenix, Arizona, United States
Chula Vista, California, United States
Irvine, California, United States
Santa Monica, California, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
South Miami, Florida, United States
Boise, Idaho, United States
Oak Lawn, Illinois, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Novi, Michigan, United States
Newark, New Jersey, United States
Farmington, New Mexico, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Arlington, Texas, United States
College Station, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
+ 24 more on CT.gov