Status:
UNKNOWN
Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study project includes a single-arm phase 2 study and a parallel 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. Two-week (14 days) and one-month (30 days) lethality rates are the ...
Eligibility Criteria
Inclusion
- Any gender
- No age limit
- 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)
- Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
- Hospitalized due to clinical/instrumental diagnosis of pneumonia
- Oxygen saturation at rest in ambient air ≤93% or requiring oxygen therapy or mechanical ventilation either non invasive or invasive (intubated)
- Patients with criteria #4 and #5 who have been already treated with tocilizumab before registration are eligible for the observational retrospective cohort
Exclusion
- Known hypersensitivity to tocilizumab or its excipients
- Known active infections or other clinical condition that contraindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician
- ALT / AST\> 5 times the upper limit of the normality
- Neutrophils \<500 / mmc
- Platelets \<50.000 / mmc
- Bowel diverticulitis or perforation
Key Trial Info
Start Date :
March 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2023
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT04317092
Start Date
March 19 2020
End Date
December 19 2023
Last Update
March 24 2023
Active Locations (27)
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1
Azienda Ospedaliera "SS. Antonio e Biagio e C. Arrigo" (Dipartimento Internistico SSD Reumatologia)
Alessandria, Italy
2
Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive)
Busto Arsizio, Italy
3
A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza)
Catania, Italy
4
AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O.
Catania, Italy