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Tocilizumab in COVID-19 Pneumonia (TOCIVID-19) (TOCIVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04317092
Recruitment Status : Active, not recruiting
First Posted : March 20, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

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

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Tocilizumab Injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : December 19, 2020
Estimated Study Completion Date : December 19, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: tocilizumab treatment
All the patients enrolled are treated with tocilizumab.
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.




Primary Outcome Measures :
  1. Lethality rate two weeks after registration [ Time Frame: up to 15 days ]
    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.

  2. Lethality rate one month after registration [ Time Frame: up to 1 month ]
    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.


Secondary Outcome Measures :
  1. Interleukin-6 level [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]
    IL-6 levels will be assessed using commercial ELISA method.

  2. Lymphocyte count [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]
    Lymphocyte count assessed by routinely used determination of blood count

  3. CRP (C-reactive protein) level [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]
    CRP is assessed by routinely used determination of CRP

  4. PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]
    calculated from arterial blood gas analyses (values from 300 to 100)

  5. Change of the SOFA (Sequential Organ Failure Assessment) [ Time Frame: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month ]
    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.

  6. Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: during treatment and up to 30 days after the last treatment dose ]
    graded according to CTCAE citeria (v5.0)

  7. Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]
    Thoracic CT scan or Chest XR

  8. Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]
    Days of hospitalization

  9. Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation

  10. Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to definitive extubation calculated from intubation (any time occurred) to extubation in days

  11. Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to independence from non-invasive mechanical ventilation calculated in days

  12. Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to independence from oxygen therapy in days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04317092


Locations
Show Show 27 study locations
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Francesco Perrone, MD, PhD Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT04317092    
Other Study ID Numbers: TOCIVID-19
2020-001110-38 ( EudraCT Number )
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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
Supporting Materials: Study Protocol
Statistical Analysis Plan (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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Institute, Naples:
COVID-19
pneumonia
tocilizumab
Interleukin-6
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections