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 @ 2:30 PM
Ignite Modification Date:
2025-12-24 @ 2:30 PM
NCT ID:
NCT04377659
Eligibility Criteria:
Inclusion Criteria:
* Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study.
* COVID-19 PCR positive on nasopharyngeal swab
* Aged \>/= 18 years old
* Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate \>/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) \< 93% on room air for nonintubated pts.
* Fever of 38.5 C or suspected respiratory infection
* IL-6 level \>/= 80 pcg/ml
* Cohort #1 - non intubated Cohort #2 - intubated
* Women of childbearing potential must have a negative serum or urine pregnancy test
* Patients receiving ongoing steroid therapy are eligible
* Patients will be allowed to receive concurrent or sequential treatment with remdesivir
Exclusion Criteria:
* Patients with uncontrolled systemic fungal and bacterial infections
* Patients with latent tuberculosis
* Patients with known hypersensitivity to tocilizumab or any component of the formulation
* Concurrent initiation of steroid therapy is not allowed
* Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04377659
Study Brief:
Protocol Section:
NCT04377659