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

Purpose

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.

Condition

  • COVID-19 Pneumonia

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Remdesivir + Tocilizumab (RDV+TCZ) 		Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
  • Drug: Remdesivir
    Participants will receive intravenous (IV) RDV
  • Drug: Tocilizumab
    Participants will receive IV TCZ
Active Comparator
Remdesivir + Placebo (RDV+Placebo) 		Participants assigned to the RDV+ placebo arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ-placebo on Day 1.
  • Drug: Remdesivir
    Participants will receive intravenous (IV) RDV
  • Drug: Placebo
    Participants will receive IV placebo matched to TCZ

More Details

Status
Completed
Sponsor
Hoffmann-La Roche

Study Contact