Phase 2
N=97
A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
COVID-19 Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT04363736 ↗Enrolled (actual)
97
Serious AEs
27.8%
Results posted
Aug 2021
Primary outcome: Primary: Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab) — 371; 849; 837; 1330 µg/mL*day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tociliuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab) |
371; 849; 837; 1330 | — |
| PRIMARY Maximum Serum Concentration (Cmax) of Tocilizumab |
82.2; 159; 150; 228 | — |
| PRIMARY Clearance (CL) of Tocilizumab |
0.451; 0.487; 0.468; 0.629 | — |
| PRIMARY Volume of the Central Compartment (Vc) of Tocilizumab |
4.14; 4.34; 4.2; 4.57 | — |
| PRIMARY Serum Concentration of C-reactive Protein (CRP) Following Administration of IV TCZ |
125.04; 115.77; 124.67; 109.19; 123.49; 118.83 | — |
| PRIMARY Serum Concentration of Ferritin Following Administration of IV TCZ |
2081.46; 1821.19; 2282.62; 1938.19; 2016.10; 2060.41 | — |
| PRIMARY Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of IV TCZ |
35869.87; 35331.04; 47037.59; 40928.43; 80880.16; 44300.00 | — |
| PRIMARY Serum Concentration of Interleukin-6 (IL-6) Following Administration of IV TCZ |
336.99; 325.96; 292.69; 638.00; 733.99; 757.17 | — |
| SECONDARY Pecentage of Participants With Adverse Events |
57.1; 45.8 | — |
| SECONDARY Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) (COVID-19) Viral Load Over Time |
30.56; 8.51; 8.38; 7.90; 3.82; 4.46 | — |
| SECONDARY Time to Real-Time Polymerase Chain Reaction (RT-PCR) Virus Negativity |
0.3389; 0.2874; 0.0665; 0.0000; 0.5068; 0.5727 | — |
| SECONDARY Proportion of Participants With Any Post-Treatment Infection |
6.1; 2.1; 2.0; 4.2; 2.0; 4.2 | — |
Summary
This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in hospitalized adult participants with moderate to severe COVID-19 pneumonia.
Eligibility Criteria
Inclusion Criteria
- Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen [e.g., respiratory, blood, urine, stool, and other bodily fluids]) and evidence of pneumonia on chest X-ray or computed tomography scan
- For severe patients, SpO2 93%, but desaturation 2 x upper limit of normal (ULN) is required
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined by the protocol
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol
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 SARS-CoV-2)
- Participants who are on a mechanical ventilator > 24 hours or extracorporeal membrane oxygenation (ECMO), in shock, or combination thereof with other organ failure requiring treatment in an ICU
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
- Receipt of oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x ULN detected within 24 hours at screening or at baseline (according to local laboratory reference ranges)
- Absolute neutrophil count (ANC) < 1000/uL at screening and baseline (according to local laboratory reference ranges)
- Platelet count < 50, 000/uL at screening and baseline (according to local laboratory reference ranges)
- Pregnancy or breastfeeding, or positive pregnancy test at a predose examination
- Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days (whichever is longer) of randomization
Data sourced from ClinicalTrials.gov (NCT04363736). 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.