Select Your Region
Global
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
- Infectious Diseases
- COVID-19 Pneumonia
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Allentown
- Baltimore
- Boise
- Boston
- Charleston
- Charlotte
- Chula Vista
- college-station
- Columbus
- Dallas
- Everett
- Farmington
- Fort Lauderdale
- Guadalajara
- Hialeah
- Houston
- Irvine
- Irving
- L'Hospitalet de Llobregat
- Madrid
- meco
- Miami
- Minas Gerais
- Morgantown
- Moscow
- Moskva
- New Haven
- New Orleans
- New York
- Newark
- Oak Lawn
- Paraná
- Philadelphia
- Phoenix
- Plano
- Portland
- Rio de Janeiro
- Salt Lake City
- Santa Monica
- South Miami
- Springfield
- São Paulo
- Temple
- torrelodones
- Washington
- West Bloomfield Township
Trial Identifier:
NCT04409262 2020-002275-34 WA42511
Trial Summary
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04409262,WA42511,2020-002275-34
Trial Identifier
Remdesivir, Tocilizumab, Placebo
Treatments
COVID-19 Pneumonia
Condition
Official Title
A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
Eligibility Criteria
All
Gender
≥12 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com