Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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 3 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
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 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)
Key Trial Info
Start Date :
April 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2020
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT04320615
Start Date
April 3 2020
End Date
July 28 2020
Last Update
June 30 2021
Active Locations (62)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
eStudySite
La Mesa, California, United States, 91942
3
David Geffen School of Medicine UCLA
Los Angeles, California, United States, 90095
4
Stanford University
Stanford, California, United States, 94305