Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT04317092
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04317092
Study Brief:
Protocol Section:
NCT04317092