Coronavirus disease 2019 (COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Actemra®/ RoActemra®
Product Name: TOCILIZUMAB
Product Code: [RO4877533]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Sponsors
F. HOFFMANN - LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged less than 18 years at the time of signing Informed Consent Form or Assent (if applicable) - Ability to comply with the study protocol, in the investigator's judgment - Hospitalized with COVID-19 confirmed per a positive polymerase chain reaction (PCR) of any specimen and evidenced by chest X-ray or CT scan - Receiving systemic corticosteroids at baseline - Oxygen saturation 92% at screening and baseline - For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 90 days after the final dose of TCZ - For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 60 days after the final dose of TCZ to avoid exposing the embryo Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Gestational age 10 x upper limit of normal (ULN) detected within 24 hours of screening - Platelet count <50,000/µL at screening - Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of TCZ - Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies or directly acting antivirals) - Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly acting antivirals) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the pharmacokinetics of tocilizumab (TCZ) through Day 28;Secondary Objective: - To characterize the pharmacodynamics of TCZ through Day 60 - To evaluate the safety of TCZ through Day 60 ;Primary end point(s): 1. Serum concentrations of TCZ at specified timepoints and derived PK parameters (maximal serum concentration [Cmax], area under the concentration-time curve up to Day 28 [AUCDays 0-28], serum concentration on Day 28 [CDay28], total clearance of drug [CL], and volume of distribution);Timepoint(s) of evaluation of this end point: 1. Up to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Durata della saturazione al 90% del recettore solubile dell’interleuchina-6 (sIL-6R) fino al Giorno 28 2. Concentrazioni di interleuchina 6 (IL-6), sIL-6R e proteina C-reattiva (CRP) in momenti definiti 3. Incidenza e gravità degli eventi avversi, con la gravità stabilita in base alla scala di classificazione secondo i Criteri terminologici comuni per gli eventi avversi del National Cancer Institute, Versione 5.0 4. Incidenza di eventi avversi seri 5. Variazione dal basale nei segni vitali mirati 6. Variazione dal basale nei risultati dei test clinici di laboratorio mirati;Timepoint(s) of evaluation of this end point: 1. Up to Day 28 2. Up to Day 60 3-4. Up to approximately Day 60 5-6. Baseline (Day 1) to Day 60 | — |
Countries
France, Germany, Greece, Italy, Poland, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed