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A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: COVID-19 Pneumonia

Interventions: Tociliuzumab

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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% 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

Locations (24)

Phoenix, Arizona, United States
Fullerton, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Oak Lawn, Illinois, United States
Park Ridge, Illinois, United States
Baltimore, Maryland, United States
Reno, Nevada, United States
Wayne, New Jersey, United States
Brooklyn, New York, United States
Jamaica, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
Sugar Land, Texas, United States