Status:
COMPLETED
A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 particip...
Eligibility Criteria
Inclusion
- 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% or PaO2/FiO2 \< 300 mmHg. If a participant is on supplemental oxygen with SpO2 \> 93%, but desaturation \</= to 93% on lower supplemental oxygen or ambient air is documented during screening, the inclusion criterion is met
- For moderate patients (those who do not qualify as severe based oxygen requirements), CRP \> 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
Exclusion
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2020
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04363736
Start Date
May 5 2020
End Date
August 12 2020
Last Update
August 31 2022
Active Locations (24)
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1
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
2
St. Jude Medical Center
Fullerton, California, United States, 92835
3
LAC + USC Medical Center
Los Angeles, California, United States, 90033
4
USC Keck Medical Center of USC
Los Angeles, California, United States, 90033