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Trial record 1 of 1 for:    NCT04320615
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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 : Active, not recruiting
First Posted : March 25, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 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 Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Actual Study Start Date : April 3, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Tocilizumab

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Clinical Status Assessed Using a 7-Category Ordinal Scale [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Incidence of Mechanical Ventilation [ Time Frame: Up to 60 days ]
  4. Ventilator-Free Days to Day 28 [ Time Frame: Up to Day 28 ]
  5. Incidence of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 60 days ]
  6. Duration of ICU Stay [ Time Frame: Up to 60 days ]
  7. 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 ]
  8. Mortality Rate [ Time Frame: Days 7, 14, 21, 28, and 60 ]
  9. Time to Hospital Discharge [ Time Frame: Up to 60 days ]
  10. Duration of Time on Supplemental Oxygen [ Time Frame: Up to 60 days ]
  11. Percentage of Participants with Adverse Events [ Time Frame: Up to 60 days ]
  12. COVID-19 (SARS-CoV-2) Viral Load Over Time [ Time Frame: Up to 60 days ]
  13. Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to 60 days ]
  14. Proportion of Participants with Post-Treatment Infection [ Time Frame: Up to 60 days ]
  15. Serum Concentration of IL-6 [ Time Frame: Up to 60 days ]
  16. Serum Concentration of sIL-6R [ Time Frame: Up to 60 days ]
  17. Serum Concentration of Ferritin [ Time Frame: Up to 60 days ]
  18. Serum Concentration of C-Reactive Protein (CRP) [ Time Frame: Up to 60 days ]
  19. Serum Concentration of TCZ [ Time Frame: Up to 60 days ]


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 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)

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): NCT04320615


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04320615    
Other Study ID Numbers: WA42380
2020-001154-22 ( EudraCT Number )
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 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