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Efficacy of Early Administration of Tocilizumab in COVID-19 Patients

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: NCT04346355
Recruitment Status : Terminated (Based on interim analysis for futility and given an enrolment rate almost nil)
First Posted : April 15, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Azienda Unità Sanitaria Locale Reggio Emilia

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Randomized Multicenter Study to Evaluate the Efficacy of Early Administration of Tocilizumab (TCZ) in Patients With COVID-19 Pneumonia
Actual Study Start Date : March 31, 2020
Actual Primary Completion Date : June 6, 2020
Actual Study Completion Date : June 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Tocilizumab

Arm Intervention/treatment
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 Name: Standard of care

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 Name: Standard of care




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Death from any cause [ Time Frame: Two weeks from participants' allocation to study arm ]
    Death

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04346355


Locations
Show Show 25 study locations
Sponsors and Collaborators
Azienda Unità Sanitaria Locale Reggio Emilia
Investigators
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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
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Responsible Party: Azienda Unità Sanitaria Locale Reggio Emilia
ClinicalTrials.gov Identifier: NCT04346355    
Other Study ID Numbers: RCT-TCZ-COVID-19
2020-001386-37 ( EudraCT Number )
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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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
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections