Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

NCT ID: NCT04317092

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-19
• Study Completion Date: 2023-12-19

Brief Summary

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

Detailed Description

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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tocilizumab treatment

All the patients enrolled are treated with tocilizumab.

Group Type: EXPERIMENTAL

Tocilizumab Injection

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Perrone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Locations

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

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33087150 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33043164 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33031955 (View on PubMed)

Other Identifiers

2020-001110-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TOCIVID-19

Identifier Type: -

Identifier Source: org_study_id