Status:
TERMINATED
Efficacy of Early Administration of Tocilizumab in COVID-19 Patients
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04346355
Start Date
March 31 2020
End Date
June 6 2020
Last Update
June 22 2020
Active Locations (25)
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1
Ospedale di Guastalla
Guastalla, RE, Italy
2
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy, 42122
3
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
4
Policlinico Sant'Orsola Malpighi
Bologna, Italy