Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

June 18, 2020 updated by: Azienda Unita Sanitaria Locale Reggio Emilia

An Open-label Randomized Multicenter Study to Evaluate the Efficacy of Early Administration of Tocilizumab (TCZ) in Patients With COVID-19 Pneumonia

The clinical study aims at assessing whether early administration of Tocilizumab compared to late administration of Tocilizumab can reduce the number of patients with COVID-19 pneumonia who require mechanical ventilation. The clinical study includes patients with recent-onset COVID-19 pneumonia who require hospital care, but not invasive or semi-invasive mechanical ventilation procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
      • Bologna, Italy
        • Policlinico Sant'Orsola Malpighi
      • Cremona, Italy
        • ASST Cremona
      • Cuneo, Italy
        • Azienda Ospedaliera S. Croce e Carle
      • Ferrara, Italy
        • Azienda Ospedaliero Universitaria Ferrara
      • Firenze, Italy
        • Azienda Ospedaliero Universitaria Careggi
      • Genova, Italy
        • Ospedale Evangelico Internazionale di Genova
      • Imperia, Italy
        • Azienda Sociosanitaria ASL 1 ,Imperia
      • La Spezia, Italy
        • Azienda Sociosanitaria ASL 5 La Spezia
      • Mantova, Italy
        • ASST Mantova - Ospedale Carlo Poma
      • Milano, Italy
        • IRCCS Istituto Auxologico Italiano Milano
      • Novara, Italy
        • Azienda Ospedaliero-Universitaria "Maggiore della Carità" di Novara
      • Padova, Italy
        • Ospedali Riuniti Padova Sud - ULSS 6 Euganea
      • Parma, Italy
        • Azienda Ospedaliero-Universitaria Parma
      • Piacenza, Italy
        • Azienda Unita Sanitaria Locale Di Piacenza
      • Pisa, Italy
        • Azienda Ospedaliera Universitaria Pisana
      • Torino, Italy
        • AO Ordine Mauriziano di Torino
      • Treviglio, Italy
        • ASST Bergamo Ovest -Treviglio
      • Treviso, Italy
        • AULSS 2 Marca Trevigiana
      • Treviso, Italy
        • AULSS2 Marca Trevigiana - Ospedale Vittorio Veneto
      • Venezia, Italy
        • AULSS 3 Serenissima Ospedale "Dell'Angelo"
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata di Verona
      • Verona, Italy
        • IRCCS Sacro Cuore Don Calabria
    • RE
      • Guastalla, RE, Italy
        • Ospedale di Guastalla
      • Reggio Emilia, RE, Italy, 42122
        • Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 18 years
  • Informed consent for participation in the study
  • Real time polymerase chain reaction (PCR) diagnosis of Sars-CoV2 infection
  • Hospitalization due to clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or pulmonary ultrasound)
  • Presence of acute respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) between 200 and 300 mm/Hg
  • Presence of exaggerated inflammatory response defined by the presence of at least 1 of the following criteria:
  • At least one body temperature measurement >38° C in the past two days;
  • Serum CRP greater than or equal to 10 mg/dl;
  • CRP increase of at least twice the basal value

Exclusion Criteria:

  • Patients with respiratory distress syndrome with arterial partial pressure of oxygen / fraction of inspired oxygen (PaO2 / FiO2) <200 mm/Hg or
  • Patients in non-invasive ventilation or
  • Patients in invasive ventilation or presence of shock or presence of concomitant organ failure that requires admission to the Intensive Care Unit
  • Severe heart and kidney failure
  • Pregnant or breastfeeding patient
  • Patient who, in the opinion of the clinician or by the patient's express will, will not go to intensive care regardless of the evolution of the lung picture.
  • Known hypersensitivity to TCZ or its excipients
  • Patient being treated with immuno-depressors or anti-rejection drugs
  • Known active infections or other clinical conditions that contraindicate TCZ and cannot be treated or resolved according to the physician's judgment
  • glutamate-pyruvate transaminase (GPT) or glutamine oxaloacetic transaminase (GOT) > 5 times the upper limit of the norm
  • Neutrophils <500 /mmc
  • Platelets <50.000 /mmc
  • Diverticulitis or intestinal perforation
  • Suspicion of latent tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm
Tocilizumab within 8 hours from entering the study + standard of care; 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
Drug: Tocilizumab
In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
Other Names:
  • Standard of care
Other: Control Arm
Standard of care; In the event of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
Drug: Tocilizumab
In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
Other Names:
  • Standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation
Time Frame: two weeks from participants' allocation to study arm
Entry into Intensive Care with invasive mechanical ventilation or death from any cause or clinical aggravation documented by the finding of a PaO2 / FiO2 ratio <150mm / Hg confirmed by a second arterial blood gas (ABG) measurement within four hours
two weeks from participants' allocation to study arm

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Death from any cause
Time Frame: Two weeks from participants' allocation to study arm
Death
Two weeks from participants' allocation to study arm
Tocilizumab toxicity
Time Frame: Two weeks from participants' allocation to study arm
Adverse events (AE) classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale
Two weeks from participants' allocation to study arm
Levels of interleukin-6 and C-reactive protein (CRP) and their correlation with the effectiveness of the treatment
Time Frame: Two weeks from participants' allocation to study arm
Levels of ferritin, lactate dehydrogenase and D-dimer and their correlation with the effectiveness of the treatment
Two weeks from participants' allocation to study arm
Evaluate the progress of the PaO2 / FiO2 ratio
Time Frame: Two weeks from participants' allocation to study arm
Changes from baseline of the PaO2 / FiO2 ratio
Two weeks from participants' allocation to study arm
Evaluate the trend over time of the lymphocyte count
Time Frame: Two weeks from participants' allocation to study arm
Changes from baseline of the lymphocyte count
Two weeks from participants' allocation to study arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Unita Sanitaria Locale Reggio Emilia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Carlo Salvarani, M.D., Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
  • Study Director: Massimo Costantini, Ph.D., Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCT-TCZ-COVID-19
  • 2020-001386-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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