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Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia

Trial Profile

Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Apr 2020

At a glance

  • Drugs Tocilizumab (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Acronyms TOCIVID-19
  • Most Recent Events

    • 03 Apr 2020 Planned number of patients changed from 330 to 440.
    • 30 Mar 2020 New trial record

Trial Overview

Purpose

This study project includes a single-arm phase 2 study and a parallel observational cohort study, enrolling patients with COVID-19 pneumonia.

Primary Endpoints

One-month mortality rate

description: 1-month mortality is defined as the ratio of patients who will alive after 1month from study start out of those registered at baseline
time_frame: up to 1 month

Other Endpoints

Interleukin-6 level

description: IL-6 levels will be assessed using commercial ELISA method.
time_frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Lymphocyte count

description: Lymphocyte count assessed by routinely used determination of blood count
time_frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

CRP (C-reactive protein) level

description: CRP is assessed by routinely used determination of CRP
time_frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)

description: calculated from arterial blood gas analyses (values from 300 to 100)
time_frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Change of the SOFA (Sequential Organ Failure Assessment)

description: It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.
time_frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

description: graded according to CTCAE citeria (v5.0)
time_frame: during treatment and up to 30 days after the last treatment dose

Radiological response

description: Thoracic CT scan or Chest XR
time_frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month)

Duration of hospitalization

description: Days of hospitalization
time_frame: from baseline up to patient's discharge (up to 1 month)

Remission of respiratory symptoms

description: time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
time_frame: up to 1 month

Remission of respiratory symptoms

description: time to definitive extubation calculated from intubation (any time occurred) to extubation in days
time_frame: up to 1 month

Remission of respiratory symptoms

description: time to independence from non-invasive mechanical ventilation calculated in days
time_frame: up to 1 month

Remission of respiratory symptoms

description: time to independence from oxygen therapy in days
time_frame: up to 1 month [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 440

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04317092 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001110-38 European Clinical Trials Database
TOCIVID19 -

Trial Dates

  • Initiation Dates

    Actual : 19 Mar 2020

  • Primary Completion Dates

    Planned : 19 Dec 2020

  • End Dates

    Planned : 19 Dec 2022

Other Details

  • Design multicentre; observational; open; prospective
  • Phase of Trial Phase II
  • Location Italy
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
TocilizumabPrimary Drug Intravenous Infusion, Solution

Product Name: TOCILIZUMAB
Investigational Medicinal Product Trade Name: RoActemra
Name of the Marketing Authorisation Holder: Roche Registration GmbH
Country which granted the Marketing Authorisation: Italy
Investigational Medicinal Product Code: RO4877533
Pharmaceutical Form: Solution for infusion
Specific paediatric formulation: information not present in eudract
IMP Routes of Administration: Intravenous use
Active Substance CAS number: 375823-41-9
Active Substance other descriptive name: TOCILIZUMAB
EV Substance code: SUB20313
Active Substance Concentration unit: mg/ml milligram(s)/millilitre
Active Substance Concentration type: equal
Active Substance Concentration: 20
Biological Origin Active Substance: yes
Recombinant medicinal product: yes

Number Of treatment arms In the trial: 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Arturo Montineri, MD A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza) Italy
Carlo Salvarani, MD
+39 0522 296684 salvarani.carlo@ausl.re.it
show details
Azienda Ospedaliero-Universitaria di Modena Italy
Carmelo Iacobello, MD AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O. Italy
Cristina Mussini, MD
0594223673 nb.protocolli@unimore.it
show details
A.O.U. di Modena (Dipartimento Medicine Specialistiche - Struttura Complessa Malattie Infettive) Italy
Demetrio Labate Grande Ospedale Metropolitano, Reggio Calabria Italy
Elisabetta Bertelli, MD
0594225868 ricercainnovazione@aou.mo.it
show details
A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione II) Italy
Enrico Clini, MD
0594225868 ricercainnovazione@aou.mo.it
show details
Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio Italy
Evelina Tacconelli, MD
045 8128243 - 8128244 evelina.tacconelli@univr.it
show details
A.O.U. Integrata di Verona (Dip. Malattie Infettive) Italy
Fabio Franzetti, MD
0331/699270 fabio.franzetti@asst-valleolona.it
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Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive) Italy
Fabio Giuliano Numis, MD
fabiogiuliano.numis@aslnapoli2nord.it
show details
Denominazione: UOC di Medicina e Chirurgia d'Accettazione e d'Urgenza dell'Ospedale Santa Maria delle Grazie di Pozzuoli Italy
Fiorentino Fragranza, MD
+39 08170672571 fiorentino.fragranza@ospedaledeicolli.it
show details
A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Anestesia Rianimazione e terapia intensiva) Italy
Francesco Cristini, MD
0541705506 - 0541705315 francesco.cristini@auslromagna.it
show details
Ospedale Infermi, AUSL della Romagna (U.O. Malattie Infettive) Italy
Francesco Dentali, MD
0332/393056 francesco.dentali@asst-settelaghi.it
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ASST Sette Laghi (Dipartimento di Medicina Interna) Italy
Francesco Perrone, MD, PhD
+390815903571 f.perrone@istitutotumori.na.it
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Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
-
Giancarlo Titolo, MD
328 4157022 giancarlo.titolo@ospedalimarchenord.it
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A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro (UOC Pronto Soccorso e Medicina d'Urgenza) Italy
Giuseppe Carpinteri, MD A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza) Italy
Maria Carmela Piccirillo, MD
+390815903615 m.piccirillo@istitutotumori.na.it
show details
-
Maria Concetta Monea, MD AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O. Italy
Maria Danzi, MD
331/6237628 maria.danzi@aulss9.veneto.it
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Ospedale Magalini (U.O. Malattie Infettive) Italy
Massimo Girardis, MD
0594225868 ricercainnovazione@aou.mo.it
show details
A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione I) Italy
Maurizio Fusari, MD
0544285918 maurizio.fusari@auslromagna.it
show details
Ospedale Santa Maria delle Croci, AUSL della Romagna (U.O. Anestesia e Rianimazione) Italy
Paola Faggioli, MD
0331449175-919 paola.faggioli@sst-ovestmi.it
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ASST OVEST MILANESE presidi Legnano - Magenta Italy
Paolo Grossi, MD
0332/393056 paolo.grossi@asst-settelaghi.it
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ASST Sette Laghi (U.O.C. Malattie Infettive e Tropicali) Italy
Roberto Cauda, MD
06 3015 4945 roberto.cauda@policlinicogemelli.it
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Policlinico Gemelli (U.O.C. Dipartimento Scienze di Laboratorio e Infettivologiche) Italy
Roberto Parrella, MD
+39 0817067584 roberto.parrella@ospedaledeicolli.it
show details
A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Malattie Infettive ad indirizzo respiratorio) Italy
Salvo Nicosia, MD A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza) Italy
Stobbione Paolo, MD
0131/206860 pstobbione@ospedale.al.it
show details
Azienda Ospedaliera "SS. Antonio e Biagio e C. Arrigo" (Dipartimento Internistico SSD Reumatologia) Italy
Vincenzo Montesarchio, MD
+39 0817065268 vincenzo.montesarchio@ospedaledeicolli.it
show details
A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Oncologia) Italy
Walter Ageno, MD
0332/393056 walter.ageno@asst-settelaghi.it
show details
ASST Sette Laghi (Dipartimento Emergenze ed Urgenze) Italy

Centres

Centre Name Location Trial Centre Country
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-
-
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro (UOC Pronto Soccorso e Medicina d'Urgenza) Pesaro 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.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Oncologia) Naples 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
A.O.U. Integrata di Verona (Dip. Malattie Infettive) Verona 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
ASST OVEST MILANESE presidi Legnano - Magenta Magenta 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
Azienda Ospedaliera "SS. Antonio e Biagio e C. Arrigo" (Dipartimento Internistico SSD Reumatologia) Alessandria Italy
Azienda Ospedaliero-Universitaria di Modena Modena Italy
Denominazione: UOC di Medicina e Chirurgia d'Accettazione e d'Urgenza dell'Ospedale Santa Maria delle Grazie di Pozzuoli Pozzuoli Italy
Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio Modena Italy
Grande Ospedale Metropolitano, Reggio Calabria Reggio Calabria Italy
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
-
Italy
Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
-
-
Ospedale Annunziata Azienda Ospedaliera di Cosenza (U.O.C. Malattie Infettive) Cosenza Italy
Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive) Busto Arsizio Italy
Ospedale Infermi, AUSL della Romagna (U.O. Malattie Infettive) Rimini Italy
Ospedale Magalini (U.O. Malattie Infettive) Villafranca Di Verona Italy
Ospedale Santa Maria delle Croci, AUSL della Romagna (U.O. Anestesia e Rianimazione) Ravenna Italy
Policlinico Gemelli (U.O.C. Dipartimento Scienze di Laboratorio e Infettivologiche) Rome Italy

Trial History

Event Date Event Type Comment
08 Apr 2020 Other trial event New source identified and integrated (ClinicalTrials.gov: NCT04317092). Updated 08 Apr 2020
03 Apr 2020 Other trial event Planned number of patients changed from 330 to 440. Updated 08 Apr 2020
30 Mar 2020 New trial record New trial record Updated 30 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
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