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

Completed · Phase 2

Conditions studied: COVID-19 Pneumonia

In brief

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.

Key facts

Study ID

NCT04363736

Run by

Hoffmann-La Roche

People needed

97

Starts

2020-05-05

Expected to finish

2020-08-12

Last updated by the study team

2022-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic - Arizona — Phoenix, Arizona, United States
• St. Jude Medical Center — Fullerton, California, United States
• LAC + USC Medical Center — Los Angeles, California, United States
• USC Keck Medical Center of USC — Los Angeles, California, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• University of Maryland — Baltimore, Maryland, United States
• Renown Institute for Heart & Vascular Health — Reno, Nevada, United States
• St Joseph's Regional Medical Center — Wayne, New Jersey, United States
• SUNY Downstate Medical Center. — Brooklyn, New York, United States
• Jamaica Hospital Medical Center — Jamaica, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Mercy St. Vincent Medical Center — Toledo, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Allegheny Health Network (Pittsburg PA) — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Michael E. DeBakey VA Medical Center — Houston, Texas, United States
• Houston Methodist Sugar Land Hospital — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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