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:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT05164133
Eligibility Criteria:
Inclusion Criteria:
* Hospitalized with COVID-19 confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, or other bodily fluid) and evidenced by chest x-ray or CT scan
* Receiving systemic corticosteroids at baseline
* Oxygen saturation \< 93% on room air, or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) to maintain oxygen saturation \> 92% at screening and baseline
Exclusion Criteria:
* Gestational age \< 37 weeks
* Known severe allergic reactions to TCZ or other monoclonal antibodies
* Active tuberculosis infection
* Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19)
* Diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (MIS-C)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments
* Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months prior to enrollment
* Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)
* Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT05164133
Study Brief:
Protocol Section:
NCT05164133