search
Back to results

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 (REMDACTA)

Primary Purpose

COVID-19 Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Remdesivir
Tocilizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Valleywise Health Medical Center
  • eStudySite - Chula Vista - PPDS
  • Hoag Hospital Irvine
  • Providence St Johns Health Center
  • Yale University School of Medicine; HIV Clinical Trials Program
  • Medstar Georgetown University Hospital
  • Holy Cross Hospital Inc
  • Larkin Community Hospital Palm Springs Campus (Hialeah)
  • University of Miami Miller School of Medicine; Clinical Reseach Building
  • Larkin Community Hospital
  • St Luke's Health System; Rheumatology Research
  • Advocate Christ Medical Center
  • Ochsner Clinic Foundation
  • University of Maryland
  • Boston Medical Center
  • Baystate Medical Center
  • Henry Ford Medical Center
  • St. Michael'S Medical Center
  • San Juan Oncology Associates
  • Wyckoff Heights Medical Center
  • Novant Health Clinical Research
  • OhioHealth Research Institute
  • Providence Saint Vincent's Medical Center
  • Lehigh Valley Hospital
  • Thomas Jefferson University
  • Medical University of South Carolina
  • The Liver Institute at Methodist Dallas
  • Baylor Scott and White Medical Center - College Station
  • Baylor University Medical Center
  • Baylor St. Luke's Medical Center
  • Ben Taub General Hospital - HCHD
  • Houston Methodist Hospital
  • Baylor Scott & White Medical Center - Irving
  • Baylor Scott & White Hospital - Plano
  • Baylor Scott & White Health
  • Intermountain LDS Hospital
  • The Providence Regional Medical Center Everett
  • West Virginia University Hospital
  • Santa Casa de Misericordia de Belo Horizonte
  • Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
  • Instituto de Pesquisa Clinica Evandro Chagas - IPEC FIOCRUZ
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • Hospital de Base de Sao Jose do Rio Preto
  • Instituto de Infectologia Emilio Ribas
  • Instituto do Coração - HCFMUSP
  • Medsi Clinic
  • O.M. Filatov City Clinical Hospital #15; Department of Surgery
  • City Pokrovskaya Hospital
  • City Clinical Hospital # 52
  • Hospital Universitario de Bellvitge
  • Hospital Universitario Principe de Asturias; Medicina Interna - Servicio de Enfermedades Infecciosas
  • Hospital Universitario HM Torrelodones
  • Hospital General Universitario de Guadalajara
  • Hospital Universitario Fundacion Jimenez Diaz.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remdesivir + Tocilizumab (RDV+TCZ)

Remdesivir + Placebo (RDV+Placebo)

Arm Description

Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.

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.

Outcomes

Primary Outcome Measures

Time to Hospital Discharge or "Ready for Discharge" up to Day 28
Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death

Secondary Outcome Measures

Time to Mechanical Ventilation or Death up to Day 28
Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time to Death up to Day 28
Time to death is defined as the time from randomization to death.
Time to Death up to Day 60
Time to death is defined as the time from randomization to death.
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28
Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28. Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)
Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event. Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.
Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)
Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28
Participants who die by Day 28 are assigned a duration of 28 days.
Difference in Mortality at Days 14, 28, and 60
Time to Recovery up to Day 28
Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category >2 or death. Participants who die are censored at day 28. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28
Defined as hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28
Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.

Full Information

First Posted
May 28, 2020
Last Updated
January 28, 2022
Sponsor
Hoffmann-La Roche
Collaborators
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04409262
Brief Title
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
Acronym
REMDACTA
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
649 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remdesivir + Tocilizumab (RDV+TCZ)
Arm Type
Experimental
Arm Description
Participants assigned to the RDV+TCZ arm will receive a 10-day treatment course of RDV, plus one infusion of TCZ on Day 1.
Arm Title
Remdesivir + Placebo (RDV+Placebo)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Intervention Description
Participants will receive intravenous (IV) RDV
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Participants will receive IV TCZ
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive IV placebo matched to TCZ
Primary Outcome Measure Information:
Title
Time to Hospital Discharge or "Ready for Discharge" up to Day 28
Description
Defined as days from randomization to hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Hospital discharge or "Ready for Discharge" is defined as an ordinal score of 1 on the 7-point ordinal scale. Participants who die are censored at Day 28. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Up to Day 28
Secondary Outcome Measure Information:
Title
Time to Mechanical Ventilation or Death up to Day 28
Description
Time to Mechanical Ventilation or Death defined as the time from randomization to the first occurrence of death or mechanical ventilation. For participants already on mechanical ventilation at baseline, only death is counted as an event.
Time Frame
Up to Day 28
Title
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 14
Description
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Day 14
Title
Time to Death up to Day 28
Description
Time to death is defined as the time from randomization to death.
Time Frame
Up to Day 28
Title
Time to Death up to Day 60
Description
Time to death is defined as the time from randomization to death.
Time Frame
Up to Day 60
Title
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-category Ordinal Scale of Clinical Status up to Day 28
Description
Defined as time from randomization to the time when at least a 2-category improvement in the 7-category ordinal scale is observed. Patients who die are censored at day 28. Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Up to Day 28
Title
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 7
Description
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Day 7
Title
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 21
Description
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Day 21
Title
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 28
Description
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Day 28
Title
Clinical Status as Assessed by the Investigator Using a 7-category Ordinal Scale of Clinical Status on Day 60
Description
Clinical status was assessed by the investigator according to the following ordinal scale categories: Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Day 60
Title
Proportion of Participants Requiring Initiation of Mechanical Ventilation Post-baseline (Participants Who Did Not Require Mechanical Ventilation at Baseline)
Description
Day 28: Participants who withdraw or die prior to Day 28 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 28, which are counted as an event. Day 60: Participants who withdraw or die prior to Day 60 are assumed to have required mechanical ventilation. Participants without mechanical ventilation prior to discharge are assumed not to have required mechanical ventilation unless they die by Day 60, which are counted as an event.
Time Frame
Day 28 and Day 60
Title
Proportion of Participants Who Are Alive and Free of Respiratory Failure at Day 28 and Day 60 (Participants Requiring Mechanical Ventilation at Baseline)
Time Frame
Day 28 and Day 60
Title
Duration of Mechanical Ventilation (Participants Requiring Mechanical Ventilation at Baseline) up to Day 28
Description
Participants who die by Day 28 are assigned a duration of 28 days.
Time Frame
Up to Day 28
Title
Difference in Mortality at Days 14, 28, and 60
Time Frame
Days 14, 28, and 60
Title
Time to Recovery up to Day 28
Description
Defined as the time from randomization to the time when an ordinal scale category of 2 (non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen) or better is observed, not followed by ordinal scale category >2 or death. Participants who die are censored at day 28. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Up to Day 28
Title
Proportion of Participants Who Are Discharged or "Ready for Discharge" up to Day 28
Description
Defined as hospital discharge or "Ready for Discharge" not followed by ordinal scale category >1, hospital readmission or death. Discharged (or "ready for discharge" as evidenced by normal temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) Non-intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen ICU, requiring intubation and mechanical ventilation ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support (e.g., vasopressors, renal replacement therapy) Death
Time Frame
Up to Day 28
Title
Proportion of Participants Who Require Initiation of Mechanical Ventilation Post-baseline or Die up to Day 28
Description
Participants already on mechanical ventilation at baseline are only counted as an event if death occurs.
Time Frame
Up to Day 28
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Adverse Events (AEs) Tabulated by Severity
Description
AEs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE Participants are counted at the highest AE grade experienced.
Time Frame
Up to Day 60
Title
Proportion of Participants With Any Post-Treatment Infection
Time Frame
Up to Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Valleywise Health Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
eStudySite - Chula Vista - PPDS
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Hoag Hospital Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Facility Name
Providence St Johns Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Yale University School of Medicine; HIV Clinical Trials Program
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06501
Country
United States
Facility Name
Medstar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Holy Cross Hospital Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Larkin Community Hospital Palm Springs Campus (Hialeah)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
University of Miami Miller School of Medicine; Clinical Reseach Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Larkin Community Hospital
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
St Luke's Health System; Rheumatology Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2393
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Henry Ford Medical Center
City
Novi
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
St. Michael'S Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Wyckoff Heights Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
11237
Country
United States
Facility Name
Novant Health Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Providence Saint Vincent's Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The Liver Institute at Methodist Dallas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Baylor Scott and White Medical Center - College Station
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ben Taub General Hospital - HCHD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott & White Medical Center - Irving
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Baylor Scott & White Hospital - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Baylor Scott & White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Intermountain LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
The Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia
City
Curitiba
State/Province
PR
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica Evandro Chagas - IPEC FIOCRUZ
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21045-900
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
Sao Bernardo Do Campo
State/Province
SP
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Instituto do Coração - HCFMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
Medsi Clinic
City
Moscow
State/Province
Adygeja
ZIP/Postal Code
143442
Country
Russian Federation
Facility Name
O.M. Filatov City Clinical Hospital #15; Department of Surgery
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
City Pokrovskaya Hospital
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
City Clinical Hospital # 52
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Principe de Asturias; Medicina Interna - Servicio de Enfermedades Infecciosas
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28005
Country
Spain
Facility Name
Hospital Universitario HM Torrelodones
City
Torrelodones
State/Province
Madrid
ZIP/Postal Code
28250
Country
Spain
Facility Name
Hospital General Universitario de Guadalajara
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz.
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

We'll reach out to this number within 24 hrs