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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19 Pneumonia

In brief

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.

Key facts

Study ID

NCT04409262

Run by

Hoffmann-La Roche

People needed

649

Starts

2020-06-16

Expected to finish

2021-03-08

Last updated by the study team

2022-02-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City Pokrovskaya Hospital — Saint Petersburg, Sankt-Peterburg, Russia
• City Clinical Hospital # 52 — Moscow, Russia
• Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
• Hospital Universitario Principe de Asturias; Medicina Interna - Servicio de Enfermedades Infecciosas — Alcalá de Henares, Madrid, Spain
• Hospital Universitario HM Torrelodones — Torrelodones, Madrid, Spain
• Hospital General Universitario de Guadalajara — Guadalajara, Spain
• Hospital Universitario Fundacion Jimenez Diaz. — Madrid, Spain
• Valleywise Health Medical Center — Phoenix, Arizona, United States
• eStudySite - Chula Vista - PPDS — Chula Vista, California, United States
• Hoag Hospital Irvine — Irvine, California, United States
• Providence St Johns Health Center — Santa Monica, California, United States
• Yale University School of Medicine; HIV Clinical Trials Program — New Haven, Connecticut, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Holy Cross Hospital Inc — Fort Lauderdale, Florida, United States
• Larkin Community Hospital Palm Springs Campus (Hialeah) — Hialeah, Florida, United States
• University of Miami Miller School of Medicine; Clinical Reseach Building — Miami, Florida, United States
• Larkin Community Hospital — South Miami, Florida, United States
• St Luke's Health System; Rheumatology Research — Boise, Idaho, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Henry Ford Medical Center — Novi, Michigan, United States
• O.M. Filatov City Clinical Hospital #15; Department of Surgery — Moskva, Moscow Oblast, Russia

Full record on ClinicalTrials.gov

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