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COVID-19 PneumoniaPhase 2TOCIVID-19NCT04317092

Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

A Phase 2 study testing Tocilizumab Injection in people with COVID-19 Pneumonia, run by National Cancer Institute, Naples at 27 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Any age
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
Tocilizumab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
27 sitesItaly
Study dates
19 Mar 2020to 19 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Italy27 sites

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

    Alessandria

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

    Busto Arsizio

  • A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza)

    Catania

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

    Catania

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

    Cosenza

  • ASST OVEST MILANESE presidi Legnano - Magenta

    Magenta

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 42100

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

    Modena

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

    Modena

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

    Modena

  • Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio

    Modena

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

    Naples, 80131

  • National Cancer Institute

    Naples, 80131

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

    Naples

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

    Naples

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

    Pesaro

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

    Pozzuoli

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

    Ravenna

  • Grande Ospedale Metropolitano, Reggio Calabria

    Reggio Calabria

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

    Rimini

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

    Rome

  • ASST Sette Laghi (Dipartimento di Medicina Interna)

    Varese

  • ASST Sette Laghi (Dipartimento Emergenze ed Urgenze)

    Varese

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

    Varese

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

    Varese

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

    Verona

  • Ospedale Magalini (U.O. Malattie Infettive)

    Villafranca di Verona

Other trials in Italy

About this study

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

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

Read the 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.

Being tested
Tocilizumab Injection
Keywords
COVID-19, pneumonia, tocilizumab, Interleukin-6
Medical subject headings
COVID-19, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tocilizumab InjectionDrug

    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.

Study groups in NCT04317092
Study groupRoleWhat they receive
tocilizumab treatmentExperimentalAll the patients enrolled are treated with tocilizumab.
Receives: Drug: Tocilizumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 15 days

  2. 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.

    Measured: up to 1 month

Secondary outcomes (12)

  1. Interleukin-6 level

    IL-6 levels will be assessed using commercial ELISA method.

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

  2. Lymphocyte count

    Lymphocyte count assessed by routinely used determination of blood count

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

  3. CRP (C-reactive protein) level

    CRP is assessed by routinely used determination of CRP

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

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

    calculated from arterial blood gas analyses (values from 300 to 100)

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

  5. Change of the SOFA (Sequential Organ Failure Assessment)

    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.

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

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

    graded according to CTCAE citeria (v5.0)

    Measured: during treatment and up to 30 days after the last treatment dose

  7. Radiological response

    Thoracic CT scan or Chest XR

    Measured: at baseline (optional), after seven days and if clinically indicated (up to 1 month)

  8. Duration of hospitalization

    Days of hospitalization

    Measured: from baseline up to patient's discharge (up to 1 month)

  9. Remission of respiratory symptoms

    time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation

    Measured: up to 1 month

  10. Remission of respiratory symptoms

    time to definitive extubation calculated from intubation (any time occurred) to extubation in days

    Measured: up to 1 month

  11. Remission of respiratory symptoms

    time to independence from non-invasive mechanical ventilation calculated in days

    Measured: up to 1 month

  12. Remission of respiratory symptoms

    time to independence from oxygen therapy in days

    Measured: up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2020
  2. Study start19 Mar 2020
  3. Primary completion19 Dec 2023 (estimated)
  4. Study completion19 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317092
Sponsor's protocol ID
TOCIVID-19
Other IDs
2020-001110-38
Acronym
TOCIVID-19
Status last verified
Mar 2023
First submitted
19 Mar 2020
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared upon reasonable request to the Principal Investigator of the study The following IPD will be available for sharing: 1. Baseline characteristics of patients 2. Treatment data 3. Safety data 4. Follow-up data

Publications

  • 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.

    PubMed 33087150

  • 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.

    PubMed 33043164

  • 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.

    PubMed 33031955

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tocilizumab Injection in people with COVID-19 Pneumonia, run by National Cancer Institute, Naples at 27 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lethality rate two weeks after registration (time frame: up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317092, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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