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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320615
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 25, 2020
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE April 3, 2020
Actual Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
Clinical Status Assessed Using a 7-Category Ordinal Scale [ Time Frame: Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
  • Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours [ Time Frame: Up to 60 days ]
  • Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to 60 days ]
  • Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
  • Ventilator-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
  • Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
  • Duration of ICU Stay [ Time Frame: Up to 60 days ]
  • Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days). If already in ICU on ventilation, failure = a one-category worsening on the ordinal scale, withdrawal, or death ]
  • Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
  • Time to Hospital Discharge [ Time Frame: Up to 60 days ]
  • Time to Recovery [ Time Frame: Up to 60 days ]
  • Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
  • COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
  • Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
  • Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
  • Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
  • Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
  • Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
  • Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
  • Serum Concentration of TCZ [ Time Frame: Up to 60 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours [ Time Frame: Up to 60 days ]
  • Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to 60 days ]
  • Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
  • Ventilator-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
  • Organ Failure-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
  • Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
  • Duration of ICU Stay [ Time Frame: Up to 60 days ]
  • Time to Clinical Failure [ Time Frame: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days) ]
  • Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
  • Time to Hospital Discharge [ Time Frame: Up to 60 days ]
  • Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
  • Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
  • COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
  • Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
  • Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
  • Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
  • Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
  • Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
  • Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
  • Serum Concentration of TCZ [ Time Frame: Up to 60 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE
  • Drug: Tocilizumab (TCZ)
    Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Experimental: Tocilizumab (TCZ) Arm
    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.
    Intervention: Drug: Tocilizumab (TCZ)
  • Placebo Comparator: Placebo Arm
    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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2020)
450
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
330
Actual Study Completion Date  ICMJE July 28, 2020
Actual Primary Completion Date June 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04320615
Other Study ID Numbers  ICMJE WA42380
2020-001154-22 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP