Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 46 for:    Actemra | covid 19
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04317092
Recruitment Status : Recruiting
First Posted : March 20, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Tracking Information
First Submitted Date  ICMJE March 19, 2020
First Posted Date  ICMJE March 20, 2020
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE March 19, 2020
Estimated Primary Completion Date December 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
One-month mortality rate [ Time Frame: up to 1 month ]
1-month mortality is defined as the ratio of patients who will alive after 1month from study start out of those registered at baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
  • 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.
  • 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
  • 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
  • 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)
  • 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.
  • 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)
  • Radiological response [ Time Frame: at baseline (optional), after seven days and if clinically indicated (up to 1 month) ]
    Thoracic CT scan or Chest XR
  • Duration of hospitalization [ Time Frame: from baseline up to patient's discharge (up to 1 month) ]
    Days of hospitalization
  • Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation
  • Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to definitive extubation calculated from intubation (any time occurred) to extubation in days
  • Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to independence from non-invasive mechanical ventilation calculated in days
  • Remission of respiratory symptoms [ Time Frame: up to 1 month ]
    time to independence from oxygen therapy in days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)
Official Title  ICMJE Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia
Brief Summary This study project includes a single-arm phase 2 study and a parallel observational 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. One-month mortality rate is the primary endpoint.

Observational cohort: 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 in principle required also for the observational cohort study. The sample size of the observational study is not defined a priori, and the cohort will close at the end of the overall project. All the patients enrolled are treated with tocilizumab.

In both study groups (phase 2 and observational study), participants will receive two doses of Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose), with an interval of 12 hours.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE COVID-19 Pneumonia
Intervention  ICMJE Drug: Tocilizumab Injection
Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose), with an interval of 12 hours.
Study Arms  ICMJE Experimental: tocilizumab treatment
All the patients enrolled are treated with tocilizumab.
Intervention: Drug: Tocilizumab Injection
Publications * Thibaud S, Tremblay D, Bhalla S, Zimmerman B, Sigel K, Gabrilove J. Protective Role of BTK Inhibitors in Patients with Chronic Lymphocytic Leukemia and COVID-19. Br J Haematol. 2020 May 20. doi: 10.1111/bjh.16863. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2020)
400
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2020)
330
Estimated Study Completion Date  ICMJE December 19, 2022
Estimated Primary Completion Date December 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Francesco Perrone, MD, PhD +390815903571 f.perrone@istitutotumori.na.it
Contact: Maria Carmela Piccirillo, MD +390815903615 m.piccirillo@istitutotumori.na.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04317092
Other Study ID Numbers  ICMJE TOCIVID-19
2020-001110-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Cancer Institute, Naples
Study Sponsor  ICMJE National Cancer Institute, Naples
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesco Perrone, MD, PhD Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
PRS Account National Cancer Institute, Naples
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP