A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia (EMPACTA)
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|ClinicalTrials.gov Identifier: NCT04372186|
Recruitment Status : Active, not recruiting
First Posted : May 1, 2020
Last Update Posted : June 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Pneumonia||Drug: Placebo Drug: Tocilizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||379 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Primary Completion Date :||August 18, 2020|
|Estimated Study Completion Date :||December 1, 2021|
Placebo Comparator: Placebo
Participants will receive one intravenous (IV) infusion of placebo, in addition to SOC. Up to one additional infusion may be given.
Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
Participants will receive one IV infusion of TCZ in addition to SOC. Up to one additional infusion may be given.
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.
No Intervention: Optional Long-Term Extension
Participants at selected sites will be followed up for approximately 12 months after hospital discharge or the end of the main study.
- Cumulative Proportion of Participants Requiring Mechanical Ventilation by Day 28 [ Time Frame: Up to Day 28 ]
- 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 ]
- 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 ]
- Mortality Rate by Day 28 [ Time Frame: Up to Day 28 ]
- 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 ]
- Percentage of Participants with Adverse Events [ Time Frame: Up to Day 60 ]
- Percentage of Participants with any Post-Treatment Bacterial and/or Fungal Infection [ Time Frame: Up to Day 60 ]
- Incidence of Post-Treatment Acute Kidney injury (defined by 50% increase of creatinine from baseline) [ Time Frame: Up to Day 60 ]
- Quality of Life (QoL) as Reported by the Short Form 36 Question Health Survey Version 2 (SF-36v2) [ Time Frame: 12 months ]
- QoL as Reported by the Euro-QoL-5D-5-L (EQ-5D-5L) Instrument [ Time Frame: 12 months ]
- QoL as Reported by Living with Idiopathic Pulmonary Fibrosis Symptoms Questionnaire-Modified (L-IPF-M) [ Time Frame: 12 months ]
- QoL as Reported by the Montreal Cognitive Assessment (MoCA) [ Time Frame: 12 months ]
- Lung Texture as Measured by High-Resolution Computed Tomography (HRCT) Scan of Chest [ Time Frame: 12 months ]
- Prevalence and Incidence of COVID-19 Antibodies [ Time Frame: 12 months ]
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
|Study Director:||Clinical Trials||Hoffmann-La Roche|