viral pneumonia caused by the new coronavirus (SARS-CoV-2) MedDRA version: 21.1 Level: PT Classification code 10035737 Term: Pneumonia viral System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: ROACTEMRA
Product Name: tocilizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Current Sponsor code: TOCILIZUMAB
Ot
Sponsors
CHU AMBROISE PARE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Positive COVID status as defined by: PCR documented SARS-CoV-2 carriage in nasopharyngeal sample or evocative thoracic scan images of COVID-19 associated with typical clinical presentation - Hospitalized patients aged = 18 and = 75 years old - Signs of severe COVID-19 pneumonia (3 of the followings) - Patient wheezing or unable to speak in full sentences while at rest/with minimal effort - Respiratory rate >22 - PaO2 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Immunosuppresion - End stage renal failure and dialysis - Life expectancy < 1 year (due to a condition other than COVID) - Active neoplasia (treated or not) - Breastfeeding and pregnant patients - Known severe allergic reactions to TCZ or other monoclonal antibodies - Non treated HIV infection, chronic B hepatitis, active C hepatitis, active tuberculosis infection - Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 6 months - Participating in other drug clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety and efficacy of the tocilizumab (Roactemra®) in hospitalized adults diagnosed with COVID-19.;Secondary Objective: Not applicable;Primary end point(s): Clinical status assessed using a 7-category ordinal scale at Day 28;Timepoint(s) of evaluation of this end point: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to clinical improvement (TTCI) defined as a National Early Warning Score 2 (NEWS2) of = 2 maintained for 24 hours - Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status - Incidence of mechanical ventilation - Ventilator-free days to Day 28 - Organ failure-free days to Day 28 - Incidence of intensive care unit (ICU) stay - Duration of ICU stay - Mortality rate up to 90 days - Time to hospital discharge or “ready for discharge” (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air) - Duration of supplemental oxygen - Fever regression at day 2 - CRP regression at day 5 - Imaging regression at 72 hours - Evaluation of AE Grade>3, SAE, SAR and SUSARs (according to NCI CTCAE v5.0).;Timepoint(s) of evaluation of this end point: end of study | — |
Countries
Belgium
Contacts
Public Contactdr Camelia Rossi
CHU AMBROISE PARE
Outcome results
None listed