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A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)

Primary Purpose

COVID-19 Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tocilizumab (TCZ)
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

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

Inclusion Criteria:

  • Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
  • SPO2 </=93% or PaO2/FiO2 <300 mmHg

Exclusion Criteria:

  • Known severe allergic reactions to TCZ or other monoclonal antibodies
  • 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
  • Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
  • Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
  • Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
  • Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor)
  • Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
  • Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab)
  • Platelet count < 50,000/mL at screening (per local lab)

Sites / Locations

  • University of California San Diego
  • eStudySite
  • David Geffen School of Medicine UCLA
  • Stanford University
  • Denver Health Medical Center
  • University of Miami Miller School of Medicine
  • Rush University Medical Center
  • University of Chicago
  • Ochsner Clinic Foundation
  • Baystate Health System
  • Mayo Clinic - PPDS
  • Hackensack University Medical Center
  • Robert Wood Johnson University Hospital/Rutgers
  • James J Peters Veterans Administration Medical Center - NAVREF
  • Duke University Medical Center
  • Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine
  • Thomas Jefferson University
  • Baylor St. Luke's Medical Center
  • Ben Taub General Hospital - HCHD
  • Intermountain Medical Group
  • Intermountain LDS Hospital
  • Evergreen Health Infectious Disease
  • Swedish Hospital Medical Center
  • Hamilton General Hospital; Pharmacy
  • St. Joseph's Healthcare Hamilton
  • University Health Network
  • Clinical Research Institute of Montreal
  • Rigshospitalet Copenhagen University Hospital
  • Hvidovre Hospital
  • Odense Universitetshospital
  • Sjællands Universitetshospital, Roskilde
  • Centre Hospitalier Departemental de Vendee
  • Centre Hospitalier et Universitaire de Limoges
  • Hôpital de La Croix Rousse
  • Hotel Dieu - Nantes
  • Hopital de la Pitie Salpetriere
  • HOPITAL COCHIN university hospital
  • CHRU de Tours, Pharmacie
  • Universitatsklinikum Dusseldorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie
  • LMU Klinikum der Universitat Munchen
  • Azienda Ospedaliera San Gerardo di Monza
  • Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria
  • Amphia Ziekenhuis
  • St. Antonius Ziekenhuis Nieuwegein
  • Erasmus MC
  • Universitair Medisch Centrum Utrecht
  • Hospital Universitario de Bellvitge
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario La Paz
  • Hospital Universitario Ramon y Cajal
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario HM Sanchinarro-CIOCC
  • Greater Glasgow and Clyde Health Board
  • Leeds Teaching Hospitals NHS Trust
  • University College Hospital
  • Royal Free Hospital
  • St George's Clinical Research Facility
  • Imperial College London
  • North Manchester General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tocilizumab (TCZ) Arm

Placebo Arm

Arm Description

Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.

Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.

Outcomes

Primary Outcome Measures

Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
Clinical status was assessed using a 7-category ordinal scale: - Discharged (or "ready for discharge") - 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 - Death

Secondary Outcome Measures

Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours
Defined as time from first dose of study drug to at least two NEWS2 assessments with a score of <=2 covering a span of at least 21.5 hours, with a maximum of 26.5 hours between the first and last of these assessments and no assessments with a score >2 in between. If one of the components of the NEWS2 score was missing at a particular time point, then the NEWS2 score was not calculated. Participants who died were censored at Day 28.
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
Time to improvement for this outcome measure was defined as the days from the first dose of study drug to when at least a 2-category improvement in clinical status (based on a 7-category ordinal scale) is observed. Participants who died were censored at Day 28.
Time to Hospital Discharge or "Ready for Discharge"
Time to Hospital Discharge was defined as the time from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </=2L supplemental oxygen) Participants who died were censored at Day 28.
Incidence of Mechanical Ventilation by Day 28
Participants who died by Day 28 were assumed to have required mechanical ventilation.
Ventilator-Free Days to Day 28
Participants who died by Day 28 were assigned 0 ventilator-free days.
Incidence of Intensive Care Unit (ICU) Stay by Day 28 (Week 4)
Participants who died by Day 28 were assumed to have required an ICU stay.
Duration of ICU Stay to Day 28 (Week 4)
Participants who died by Day 28 were assigned a duration from the first dose of study drug to Day 28 at hour 23:59:59.
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
Clinical status was assessed using a 7-category ordinal scale: - Discharged (or "ready for discharge") - 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 - Death
Time to Clinical Failure to Day 28 (Week 4)
Time to clinical failure was defined as the number of days from the first dose of study drug to the first occurrence on study of death, mechanical ventilation, ICU admission, or study withdrawal prior to discharge, whichever occurs first.
Mortality Rate at Day 28 (Week 4)
Time to Recovery to Day 28 (Week 4)
Time to recovery was defined as the number of days from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) or non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen. Participants who died were censored at Day 28.
Duration of Supplemental Oxygen to Day 28 (Week 4)
Participants who died by Day 28 were assigned a duration of 28 days of supplemental oxygen.

Full Information

First Posted
March 23, 2020
Last Updated
June 28, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04320615
Brief Title
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Acronym
COVACTA
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2020 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
July 28, 2020 (Actual)

3. Sponsor/Collaborators

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

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, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe 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
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab (TCZ) Arm
Arm Type
Experimental
Arm Description
Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab (TCZ)
Intervention Description
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
Primary Outcome Measure Information:
Title
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
Description
Clinical status was assessed using a 7-category ordinal scale: - Discharged (or "ready for discharge") - 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 - Death
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours
Description
Defined as time from first dose of study drug to at least two NEWS2 assessments with a score of <=2 covering a span of at least 21.5 hours, with a maximum of 26.5 hours between the first and last of these assessments and no assessments with a score >2 in between. If one of the components of the NEWS2 score was missing at a particular time point, then the NEWS2 score was not calculated. Participants who died were censored at Day 28.
Time Frame
Up to Day 28
Title
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
Description
Time to improvement for this outcome measure was defined as the days from the first dose of study drug to when at least a 2-category improvement in clinical status (based on a 7-category ordinal scale) is observed. Participants who died were censored at Day 28.
Time Frame
Up to Day 28
Title
Time to Hospital Discharge or "Ready for Discharge"
Description
Time to Hospital Discharge was defined as the time from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </=2L supplemental oxygen) Participants who died were censored at Day 28.
Time Frame
Up to Day 28
Title
Incidence of Mechanical Ventilation by Day 28
Description
Participants who died by Day 28 were assumed to have required mechanical ventilation.
Time Frame
Up to Day 28
Title
Ventilator-Free Days to Day 28
Description
Participants who died by Day 28 were assigned 0 ventilator-free days.
Time Frame
Up to Day 28
Title
Incidence of Intensive Care Unit (ICU) Stay by Day 28 (Week 4)
Description
Participants who died by Day 28 were assumed to have required an ICU stay.
Time Frame
Up to Day 28
Title
Duration of ICU Stay to Day 28 (Week 4)
Description
Participants who died by Day 28 were assigned a duration from the first dose of study drug to Day 28 at hour 23:59:59.
Time Frame
Up to Day 28
Title
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
Description
Clinical status was assessed using a 7-category ordinal scale: - Discharged (or "ready for discharge") - 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 - Death
Time Frame
Day 14
Title
Time to Clinical Failure to Day 28 (Week 4)
Description
Time to clinical failure was defined as the number of days from the first dose of study drug to the first occurrence on study of death, mechanical ventilation, ICU admission, or study withdrawal prior to discharge, whichever occurs first.
Time Frame
Up to Day 28
Title
Mortality Rate at Day 28 (Week 4)
Time Frame
Day 28
Title
Time to Recovery to Day 28 (Week 4)
Description
Time to recovery was defined as the number of days from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) or non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen. Participants who died were censored at Day 28.
Time Frame
Up to Day 28
Title
Duration of Supplemental Oxygen to Day 28 (Week 4)
Description
Participants who died by Day 28 were assigned a duration of 28 days of supplemental oxygen.
Time Frame
Up to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan SPO2 </=93% or PaO2/FiO2 <300 mmHg Exclusion Criteria: Known severe allergic reactions to TCZ or other monoclonal antibodies 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 Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor) Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor) Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab) Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab) Platelet count < 50,000/mL at screening (per local lab)
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
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
David Geffen School of Medicine UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Clinic Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Baystate Health System
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Mayo Clinic - PPDS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Robert Wood Johnson University Hospital/Rutgers
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
James J Peters Veterans Administration Medical Center - NAVREF
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
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
Intermountain Medical Group
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Intermountain LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Evergreen Health Infectious Disease
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Swedish Hospital Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Hamilton General Hospital; Pharmacy
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Clinical Research Institute of Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Rigshospitalet Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sjællands Universitetshospital, Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Centre Hospitalier Departemental de Vendee
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hospitalier et Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hotel Dieu - Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital de la Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
HOPITAL COCHIN university hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHRU de Tours, Pharmacie
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Universitatsklinikum Dusseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
LMU Klinikum der Universitat Munchen
City
Munchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Azienda Ospedaliera San Gerardo di Monza
City
Monza MI
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro-CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Greater Glasgow and Clyde Health Board
City
Glasgow
ZIP/Postal Code
G12 8TA
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7AU
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QS
Country
United Kingdom
Facility Name
St George's Clinical Research Facility
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom

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 https://vivli.org. Further details on Roche's criteria for eligible studies are available here: https://vivli.org. 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
Citations:
PubMed Identifier
35475258
Citation
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Results Reference
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PubMed Identifier
34612846
Citation
Tom J, Bao M, Tsai L, Qamra A, Summers D, Carrasco-Triguero M, McBride J, Rosenberger CM, Lin CJF, Stubbings W, Blyth KG, Carratala J, Francois B, Benfield T, Haslem D, Bonfanti P, van der Leest CH, Rohatgi N, Wiese L, Luyt CE, Kheradmand F, Rosas IO, Cai F. Prognostic and Predictive Biomarkers in Patients With Coronavirus Disease 2019 Treated With Tocilizumab in a Randomized Controlled Trial. Crit Care Med. 2022 Mar 1;50(3):398-409. doi: 10.1097/CCM.0000000000005229.
Results Reference
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PubMed Identifier
33631066
Citation
Rosas IO, Brau N, Waters M, Go RC, Hunter BD, Bhagani S, Skiest D, Aziz MS, Cooper N, Douglas IS, Savic S, Youngstein T, Del Sorbo L, Cubillo Gracian A, De La Zerda DJ, Ustianowski A, Bao M, Dimonaco S, Graham E, Matharu B, Spotswood H, Tsai L, Malhotra A. Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia. N Engl J Med. 2021 Apr 22;384(16):1503-1516. doi: 10.1056/NEJMoa2028700. Epub 2021 Feb 25.
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A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

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