This study project includes a single-arm phase 2 study and a parallel cohort study,enrolling patients with COVID-19 pneumonia.
Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the
patients enrolled are treated with tocilizumab. Two-week (14 days) and one-month (30
days) lethality rates are the co-primary endpoints.
The parallel cohort includes patients who are treated with tocilizumab and cannot enter
the phase 2 study because:
1. emergency conditions or infrastructural or operational limits prevented registration
before the administration of the experimental drug or
2. they had been intubated more than 24 hours before registration or
3. the phase 2 study has been closed due to reached sample size.
This means that, after closure of the phase 2 enrolment, patients who might be eligible
for the phase 2 study will be included in the observational cohort study.
The same information planned for the phase 2 cohort is required also for the parallel
cohort study whose sample size is not defined a priori, and that will close at the end of
the overall project. All the patients enrolled are treated with tocilizumab.
In both study groups (phase 2 and parallel cohort), participants receive one dose of
Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose). A second administration (same
dose) can be given after 12 hours if respiratory function has not recovered, at
discretion of the Investigator.
Drug: Tocilizumab Injection
Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose). A second administration (same
dose) can be given after 12 hours if respiratory function has not recovered, at
discretion of the Investigator.
Inclusion Criteria:
1. Any gender
2. No age limit
3. Informed consent for participation in the study (consent can be oral if a written
consent cannot be expressed. If the subject is incapable of giving an informed
consent and an authorized representative is not available without a delay that
would, in the opinion of the Investigator, compromise the potential life-saving
effect of the treatment this can be administered without consent. Consent to remain
in the research should be sought as soon the conditions of the patient will allow
it)
4. Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
5. Hospitalized due to clinical/instrumental diagnosis of pneumonia
6. Oxygen saturation at rest in ambient air ≤93% or requiring oxygen therapy or
mechanical ventilation either non invasive or invasive (intubated)
7. Patients with criteria #4 and #5 who have been already treated with tocilizumab
before registration are eligible for the observational retrospective cohort
Exclusion Criteria:
1. Known hypersensitivity to tocilizumab or its excipients
2. Known active infections or other clinical condition that contraindicate tocilizumab
and cannot be treated or solved according to the judgement of the clinician
3. ALT / AST> 5 times the upper limit of the normality
4. Neutrophils <500 / mmc
5. Platelets <50.000 / mmc
6. Bowel diverticulitis or perforation
Azienda Ospedaliera "SS. Antonio e Biagio e C. Arrigo" (Dipartimento Internistico SSD Reumatologia)
Alessandria, Italy
Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive)
Busto Arsizio, Italy
A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza)
Catania, Italy
AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O.
Catania, Italy
Ospedale Annunziata Azienda Ospedaliera di Cosenza (U.O.C. Malattie Infettive)
Cosenza, Italy
ASST OVEST MILANESE presidi Legnano - Magenta
Magenta, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy
A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione I)
Modena, Italy
A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione II)
Modena, Italy
A.O.U. di Modena (Dipartimento Medicine Specialistiche - Struttura Complessa Malattie Infettive)
Modena, Italy
Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio
Modena, Italy
A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Oncologia)
Naples, Italy
National Cancer Institute
Naples, Italy
A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Anestesia Rianimazione e terapia intensiva)
Naples, Italy
A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Malattie Infettive ad indirizzo respiratorio)
Naples, Italy
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro (UOC Pronto Soccorso e Medicina d'Urgenza)
Pesaro, Italy
Denominazione: UOC di Medicina e Chirurgia d'Accettazione e d'Urgenza dell'Ospedale Santa Maria delle Grazie di Pozzuoli
Pozzuoli, Italy
Ospedale Santa Maria delle Croci, AUSL della Romagna (U.O. Anestesia e Rianimazione)
Ravenna, Italy
Grande Ospedale Metropolitano, Reggio Calabria
Reggio Calabria, Italy
Ospedale Infermi, AUSL della Romagna (U.O. Malattie Infettive)
Rimini, Italy
Policlinico Gemelli (U.O.C. Dipartimento Scienze di Laboratorio e Infettivologiche)
Rome, Italy
ASST Sette Laghi (Dipartimento di Medicina Interna)
Varese, Italy
ASST Sette Laghi (Dipartimento Emergenze ed Urgenze)
Varese, Italy
ASST Sette Laghi (U.O.C. Anestesia e Rianimazione Neurochirurgica e Generale)
Varese, Italy
ASST Sette Laghi (U.O.C. Malattie Infettive e Tropicali)
Varese, Italy
A.O.U. Integrata di Verona (Dip. Malattie Infettive)
Verona, Italy
Ospedale Magalini (U.O. Malattie Infettive)
Villafranca Di Verona, Italy
Francesco Perrone, MD, PhD, Principal Investigator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale