Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

NCT04317092 | Unknown Phase 2 DMC

• 2 other identifiers: TOCIVID-192020-001110-38
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 27

Brief Summary

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

Conditions

COVID-19 Pneumonia

Keywords

COVID-19; pneumonia; tocilizumab; Interleukin-6

Outcome Measures

Primary Outcomes (2)

• Lethality rate two weeks after registration

  2-week lethality is defined as the ratio of the number of subjects dead within 14 days from study start out of phase 2 patients with baseline information.

  up to 15 days

• Lethality rate one month after registration

  1-month lethality is defined as the ratio of the number of subjects dead within 30 days from study start out of phase 2 patients with baseline information.

  up to 1 month

Secondary Outcomes (12)

• Interleukin-6 level

  baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

• Lymphocyte count

  baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

• CRP (C-reactive protein) level

  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)

  baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

• Change of the SOFA (Sequential Organ Failure Assessment)

  baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Study Arms (1)

tocilizumab treatment

EXPERIMENTAL

All the patients enrolled are treated with tocilizumab.

Drug: Tocilizumab Injection

Interventions

Tocilizumab Injection DRUG

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.

tocilizumab treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender
• No age limit
• 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)
• Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
• Hospitalized due to clinical/instrumental diagnosis of pneumonia
• Oxygen saturation at rest in ambient air ≤93% or requiring oxygen therapy or mechanical ventilation either non invasive or invasive (intubated)
• Patients with criteria #4 and #5 who have been already treated with tocilizumab before registration are eligible for the observational retrospective cohort

You may not qualify if:

• Known hypersensitivity to tocilizumab or its excipients
• Known active infections or other clinical condition that contraindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician
• ALT / AST\> 5 times the upper limit of the normality
• Neutrophils \<500 / mmc
• Platelets \<50.000 / mmc
• Bowel diverticulitis or perforation

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (27)

Azienda Ospedaliera "SS. Antonio e Biagio e C. Arrigo" (Dipartimento Internistico SSD Reumatologia)

Alessandria, Italy

Location

Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive)

Busto Arsizio, Italy

Location

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

Location

AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O.

Catania, Italy

Location

Ospedale Annunziata Azienda Ospedaliera di Cosenza (U.O.C. Malattie Infettive)

Cosenza, Italy

Location

ASST OVEST MILANESE presidi Legnano - Magenta

Magenta, Italy

Location

Azienda Ospedaliero-Universitaria di Modena

Modena, 42100, Italy

Location

A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione I)

Modena, Italy

Location

A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione II)

Modena, Italy

Location

A.O.U. di Modena (Dipartimento Medicine Specialistiche - Struttura Complessa Malattie Infettive)

Modena, Italy

Location

Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio

Modena, Italy

Location

A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Oncologia)

Naples, 80131, Italy

Location

National Cancer Institute

Naples, 80131, Italy

Location

A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Anestesia Rianimazione e terapia intensiva)

Naples, Italy

Location

A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Malattie Infettive ad indirizzo respiratorio)

Naples, Italy

Location

A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro (UOC Pronto Soccorso e Medicina d'Urgenza)

Pesaro, Italy

Location

Denominazione: UOC di Medicina e Chirurgia d'Accettazione e d'Urgenza dell'Ospedale Santa Maria delle Grazie di Pozzuoli

Pozzuoli, Italy

Location

Ospedale Santa Maria delle Croci, AUSL della Romagna (U.O. Anestesia e Rianimazione)

Ravenna, Italy

Location

Grande Ospedale Metropolitano, Reggio Calabria

Reggio Calabria, Italy

Location

Ospedale Infermi, AUSL della Romagna (U.O. Malattie Infettive)

Rimini, Italy

Location

Policlinico Gemelli (U.O.C. Dipartimento Scienze di Laboratorio e Infettivologiche)

Rome, Italy

Location

ASST Sette Laghi (Dipartimento di Medicina Interna)

Varese, Italy

Location

ASST Sette Laghi (Dipartimento Emergenze ed Urgenze)

Varese, Italy

Location

ASST Sette Laghi (U.O.C. Anestesia e Rianimazione Neurochirurgica e Generale)

Varese, Italy

Location

ASST Sette Laghi (U.O.C. Malattie Infettive e Tropicali)

Varese, Italy

Location

A.O.U. Integrata di Verona (Dip. Malattie Infettive)

Verona, Italy

Location

Ospedale Magalini (U.O. Malattie Infettive)

Villafranca di Verona, Italy

Location

Related Publications (3)

• Perrone F, Piccirillo MC, Ascierto PA, Salvarani C, Parrella R, Marata AM, Popoli P, Ferraris L, Marrocco-Trischitta MM, Ripamonti D, Binda F, Bonfanti P, Squillace N, Castelli F, Muiesan ML, Lichtner M, Calzetti C, Salerno ND, Atripaldi L, Cascella M, Costantini M, Dolci G, Facciolongo NC, Fraganza F, Massari M, Montesarchio V, Mussini C, Negri EA, Botti G, Cardone C, Gargiulo P, Gravina A, Schettino C, Arenare L, Chiodini P, Gallo C; TOCIVID-19 investigators, Italy. Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial. J Transl Med. 2020 Oct 21;18(1):405. doi: 10.1186/s12967-020-02573-9.

  PMID: 33087150 DERIVED

• Chiodini P, Arenare L, Piccirillo MC, Perrone F, Gallo C. A phase 2, open label, multicenter, single arm study of tocilizumab on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia (TOCIVID-19 trial): Statistical analysis plan. Contemp Clin Trials Commun. 2020 Dec;20:100665. doi: 10.1016/j.conctc.2020.100665. Epub 2020 Oct 7.

  PMID: 33043164 DERIVED

• Piccirillo MC, Ascierto P, Atripaldi L, Cascella M, Costantini M, Dolci G, Facciolongo N, Fraganza F, Marata A, Massari M, Montesarchio V, Mussini C, Negri EA, Parrella R, Popoli P, Botti G, Arenare L, Chiodini P, Gallo C, Salvarani C, Perrone F. TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol. Contemp Clin Trials. 2020 Nov;98:106165. doi: 10.1016/j.cct.2020.106165. Epub 2020 Oct 6.

  PMID: 33031955 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Francesco Perrone, MD, PhD

  Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: March 19, 2020
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After peer-reviewed publication of the primary results, with no time limits
• Access Criteria: Motivated requests to access to IPD are to be sent by email to the Principal Investigator (f.perrone@istitutotumori.na.it)

Locations

IT (27)