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
Brief 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.

Completed
COVID-19 Pneumonia

Drug: Remdesivir

Participants will receive intravenous (IV) RDV

Drug: Tocilizumab

Participants will receive IV TCZ

Drug: Placebo

Participants will receive IV placebo matched to TCZ

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

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
Brazil
Russian Federation
Spain
United States
Locations

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, 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

St. Michael'S Medical Center
Newark, New Jersey, United States

San Juan Oncology Associates
Farmington, New Mexico, United States

Wyckoff Heights Medical Center
Staten Island, New York, United States

Novant Health Clinical Research
Charlotte, North Carolina, United States

OhioHealth Research Institute
Columbus, Ohio, United States

Providence Saint Vincent's Medical Center
Portland, Oregon, United States

Lehigh Valley Hospital
Allentown, Pennsylvania, United States

Thomas Jefferson University
Philadelphia, Pennsylvania, United States

Medical University of South Carolina
Charleston, South Carolina, United States

The Liver Institute at Methodist Dallas
Arlington, Texas, United States

Baylor Scott and White Medical Center - College Station
College Station, Texas, United States

Baylor University Medical Center
Dallas, Texas, United States

Baylor St. Luke's Medical Center
Houston, Texas, United States

Ben Taub General Hospital - HCHD
Houston, Texas, United States

Houston Methodist Hospital
Houston, Texas, United States

Baylor Scott & White Medical Center - Irving
Irving, Texas, United States

Baylor Scott & White Hospital - Plano
Plano, Texas, United States

Baylor Scott & White Health
Temple, Texas, United States

Intermountain LDS Hospital
Salt Lake City, Utah, United States

The Providence Regional Medical Center Everett
Everett, Washington, United States

West Virginia University Hospital
Morgantown, West Virginia, United States

Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, MG, Brazil

Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
Curitiba, PR, Brazil

Instituto de Pesquisa Clinica Evandro Chagas - IPEC FIOCRUZ
Rio de Janeiro, RJ, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos
Sao Bernardo Do Campo, SP, Brazil

Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto, SP, Brazil

Instituto de Infectologia Emilio Ribas
Sao Paulo, SP, Brazil

Instituto do Coração - HCFMUSP
Sao Paulo, SP, Brazil

Medsi Clinic
Moscow, Adygeja, Russian Federation

O.M. Filatov City Clinical Hospital #15; Department of Surgery
Moskva, Moskovskaja Oblast, Russian Federation

City Pokrovskaya Hospital
Sankt-peterburg, Sankt Petersburg, Russian Federation

City Clinical Hospital # 52
Moscow, Russian Federation

Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Principe de Asturias; Medicina Interna - Servicio de Enfermedades Infecciosas
Alcala 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

Clinical Trials, Study Director
Hoffmann-La Roche

Gilead Sciences
NCT Number
MeSH Terms
COVID-19
Pneumonia
Remdesivir