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Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Collaborating Sponsors:

Gilead Sciences

Conditions:

COVID-19 Pneumonia

Eligibility:

All Genders

12+ years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 16 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 8 2021

    Estimated Enrollment :

    649 Patients enrolled

    Trial Details

    Trial ID

    NCT04409262

    Start Date

    June 16 2020

    End Date

    March 8 2021

    Last Update

    February 14 2022

    Active Locations (54)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 14 (54 locations)

    1

    Valleywise Health Medical Center

    Phoenix, Arizona, United States, 85008

    2

    eStudySite - Chula Vista - PPDS

    Chula Vista, California, United States, 91911

    3

    Hoag Hospital Irvine

    Irvine, California, United States, 92612

    4

    Providence St Johns Health Center

    Santa Monica, California, United States, 90404