E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
viral pneumonia caused by the new coronavirus (SARS-CoV-2) |
|
E.1.1.1 | Medical condition in easily understood language |
viral pneumonia caused by the new coronavirus (SARS-CoV-2) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035737 |
E.1.2 | Term | Pneumonia viral |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate the safety
and efficacy of the tocilizumab (Roactemra®) in hospitalized adults diagnosed with COVID-19. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 mmHg or SpO2 <90%
- Repeated chest imaging is significantly worsening
despite being on standard of care, which may include anti-viral treatment, low dose steroids
and antibiotics. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical status assessed using a 7-category ordinal scale at Day 28 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard of care which could include medicinal products |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |