Phase 3
N=438
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
COVID-19 Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04320615 ↗Enrolled (actual)
438
Serious AEs
41.1%
Results posted
Jun 2021
Primary outcome: Primary: Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4) — 56.5; 49.3; 2.0; 5.6 Percentage of Participants — p=0.3600
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tocilizumab (TCZ) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4) |
56.5; 49.3; 2.0; 5.6; 4.8; 2.8 | 0.3600 |
| SECONDARY Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours |
NA; NA | 0.0443 sig |
| SECONDARY Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status |
14.0; 18.0 | 0.0820 |
| SECONDARY Time to Hospital Discharge or "Ready for Discharge" |
20.0; 28.0 | 0.0370 sig |
| SECONDARY Incidence of Mechanical Ventilation by Day 28 |
54.4; 60.4; 27.9; 36.7 | 0.0996 |
| SECONDARY Ventilator-Free Days to Day 28 |
22.0; 16.5 | 0.3202 |
| SECONDARY Incidence of Intensive Care Unit (ICU) Stay by Day 28 (Week 4) |
66.0; 71.5; 21.3; 35.9 | 0.1514 |
| SECONDARY Duration of ICU Stay to Day 28 (Week 4) |
9.8; 15.5 | 0.0454 sig |
| SECONDARY Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14 |
39.8; 29.9; 6.1; 4.9; 6.5; 11.1 | 0.0548 |
| SECONDARY Time to Clinical Failure to Day 28 (Week 4) |
NA; NA | 0.1627 |
| SECONDARY Mortality Rate at Day 28 (Week 4) |
19.7; 19.4 | 0.9410 |
| SECONDARY Time to Recovery to Day 28 (Week 4) |
16.0; 24.0 | 0.0528 |
| SECONDARY Duration of Supplemental Oxygen to Day 28 (Week 4) |
26.5; 28.0 | 0.0477 sig |
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.
Eligibility 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 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)
Data sourced from ClinicalTrials.gov (NCT04320615). 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.