COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04363736

Clinical Trials Hoffmann-La Roche

global-roche-genentech-trials@gene.com

2020-04-27

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

None

2

Hoffmann-La Roche

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

97

Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab);Clearance (CL) of Tocilizumab;Maximum Serum Concentration (Cmax) of Tocilizumab;Serum Concentration of C-reactive Protein (CRP) Following Administration of IV TCZ;Serum Concentration of Ferritin Following Administration of IV TCZ;Serum Concentration of Interleukin-6 (IL-6) Following Administration of IV TCZ;Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of IV TCZ;Volume of the Central Compartment (Vc) of Tocilizumab

None

Phase 2

[{"arm_notes": "4mg/kg", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "8mg/kg", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]