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A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia

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ClinicalTrials.gov Identifier: NCT04372186
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study will evaluate the efficacy and safety of tocilizumab (TCZ) compared with a placebo in combination with standard of care (SOC) in hospitalized participants with COVID-19 pneumonia.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Placebo Drug: Tocilizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : August 5, 2020
Estimated Study Completion Date : October 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Tocilizumab

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
Drug: Placebo
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.

Experimental: Tocilizumab
Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
Drug: Tocilizumab
Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.




Primary Outcome Measures :
  1. Cumulative Proportion of Participants Requiring Mechanical Ventilation by Day 28 [ Time Frame: Up to Day 28 ]

Secondary Outcome Measures :
  1. Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to Day 28 ]
  2. Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first) [ Time Frame: Up to Day 28 ]
  3. Mortality Rate by Day 28 [ Time Frame: Up to Day 28 ]
  4. Time to Hospital Discharge or "Ready for Discharge" (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or >/= 2 liters (L) supplemental oxygen) [ Time Frame: Up to Day 28 ]
  5. Percentage of Participants with Adverse Events [ Time Frame: Up to Day 60 ]
  6. Percentage of Participants with any Post-Treatment Bacterial and/or Fungal Infection [ Time Frame: Up to Day 60 ]
  7. Incidence of Post-Treatment Acute Kidney injury (defined by 50% increase of creatinine from baseline) [ Time Frame: Up to Day 60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Hospitalized
  • COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
  • SpO2 < 94% while on ambient air

Exclusion Criteria

  • Known severe allergic reactions to TCZ or other monoclonal antibodies
  • Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation
  • 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
  • Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer
  • Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
  • Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges)
  • Absolute neutrophil count (ANC) < 1000/uL at screening (according to local laboratory reference ranges)
  • Platelet count < 50,000/uL at screening (according to local laboratory reference ranges)
  • 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 Medical 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
  • Any history of Diverticulitis or GI perforation
  • Use of systemic corticosteroids unless on a stable chronic dose

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372186


Contacts
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Contact: Reference Study ID Number: ML42528 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 global-roche-genentech-trials@gene.com

Locations
Show Show 68 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04372186    
Other Study ID Numbers: ML42528
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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)


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections