Overview

Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)

Status:
Active, not recruiting

Trial end date:
2022-12-19

Target enrollment:
0

Participant gender:
All

Summary

This study project includes a single-arm phase 2 study and a parallel cohort study, enrolling patients with COVID-19 pneumonia.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Cancer Institute, Naples

Criteria

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