Phase 3
Completed N=377
A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
Source: ClinicalTrials.gov NCT04372186 ↗Enrolled (actual)
377
Serious AEs
16.7%
Results posted
Sep 2021
Primary outcomePrimary: Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28 — 12.04; 19.26 Percentage of Participants
◆ Published Evidence
Highly cited
1,326citations · ~265 / year
Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia.
Summary
This study (EMPACTA) will a) 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, and b) include an optional long-term extension for eligible participants to explore the long-term sequelae of resolved COVID-19 pneumonia.
Linked Publications (2)
-
Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia.
-
The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Proportion of Participants Who Died or Required Mechanical Ventilation by Day 28 |
12.04; 19.26 | — |
| SECONDARY 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) |
6.0; 7.5 | — |
| SECONDARY Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status |
6.0; 7.0 | — |
| SECONDARY Time to Clinical Failure, Defined as the Time to Death, Mechanical Ventilation, ICU Admission, or Withdrawal (Whichever Occurred First) |
NA; NA | — |
| SECONDARY Mortality Rate by Day 28 |
10.4; 8.6 | — |
| SECONDARY Clinical Status on 7-Category Ordinal Scale at Day 28 |
85.9; 82.8; 0.4; 1.6; 2.0; 0.8 | — |
| SECONDARY Percentage of Participants With Adverse Events |
50.8; 52.8 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized
- COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
- SpO2 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
Data sourced from ClinicalTrials.gov (NCT04372186) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.