ClinicalTrials.gov

History of Changes for Study: NCT04320615
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA)
Latest version (submitted June 28, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 23, 2020 None (earliest Version on record)
2 March 26, 2020 Arms and Interventions, Eligibility and Study Status
3 April 6, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 April 20, 2020 Contacts/Locations, IPDSharing and Study Status
5 April 22, 2020 Study Status, Contacts/Locations, Outcome Measures and Eligibility
6 April 24, 2020 Contacts/Locations and Study Status
7 May 28, 2020 Contacts/Locations, Study Status and Study Design
8 May 28, 2020 Recruitment Status, Contacts/Locations, Study Status and Study Design
9 June 25, 2020 Study Status, Contacts/Locations and Outcome Measures
10 July 29, 2020 Recruitment Status and Study Status
11 September 23, 2020 Study Status
12 June 23, 2021
Quality Control Review has not concluded Returned: June 24, 2021
Outcome Measures, Study Status, Contacts/Locations, Document Section and Study Design
13 June 28, 2021 Study Status and More Information
Comparison Format:

Scroll up to access the controls

Study NCT04320615
Submitted Date:  March 23, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: WA42380
Brief Title: A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (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
Secondary IDs: 2020-001154-22 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: April 3, 2020
Primary Completion: August 31, 2021 [Anticipated]
Study Completion: September 30, 2021 [Anticipated]
First Submitted: March 23, 2020
First Submitted that
Met QC Criteria:
March 23, 2020
First Posted: March 25, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 23, 2020
Last Update Posted: March 25, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: COVID-19 Pneumonia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 330 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 will 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.
Drug: Placebo
Participants will receive 1 dose of IV placebo matched to TCZ.
Open or close this module Outcome Measures
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. Organ Failure-Free Days to Day 28
[ Time Frame: Up to Day 28 ]

6. Incidence of Intensive Care Unit (ICU) Stay
[ Time Frame: Up to 60 days ]

7. Duration of ICU Stay
[ Time Frame: Up to 60 days ]

8. 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) ]

9. Mortality Rate
[ Time Frame: Days 7, 14, 21, 28, and 60 ]

10. Time to Hospital Discharge
[ Time Frame: Up to 60 days ]

11. Duration of Time on Supplemental Oxygen
[ Time Frame: Up to 60 days ]

12. Percentage of Participants with Adverse Events
[ Time Frame: Up to 60 days ]

13. COVID-19 (SARS-CoV-2) Viral Load Over Time
[ Time Frame: Up to 60 days ]

14. Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity
[ Time Frame: Up to 60 days ]

15. Proportion of Participants with Post-Treatment Infection
[ Time Frame: Up to 60 days ]

16. Serum Concentration of IL-6
[ Time Frame: Up to 60 days ]

17. Serum Concentration of sIL-6R
[ Time Frame: Up to 60 days ]

18. Serum Concentration of Ferritin
[ Time Frame: Up to 60 days ]

19. Serum Concentration of C-Reactive Protein (CRP)
[ Time Frame: Up to 60 days ]

20. Serum Concentration of TCZ
[ Time Frame: Up to 60 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 6 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
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: WA42380 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728
Email: global-roche-genentech-trials@gene.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com).

Further details on Roche's criteria for eligible studies are available here: https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx 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

Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services