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

• Status: Completed
• Trial end date: 2021-03-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Gilead Sciences
• Treatments: Remdesivir

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