Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinical Response in Maximum Temperature (Tmax)	Assessed for the 24 hour period after tocilizumab administration	Number of Participants with Clinical Response in Maximum Temperature (Tmax)
Primary	Number of Participants With Biochemical Response as Determined by CRP Response	Assessed every 24 hours during patient's hospitalization, up to 4 weeks after tocilizumab administration	Number of Participants with Biochemical Response as determined by CRP Response. Defined as at least 25% decrease in CRP from baseline at least 16 hours after administration of drug.
Secondary	Overall Survival	28 days	28-Day Overall Survival is defined as the status of the patient at the end of 28 days, beginning from the time of the first dose of tocilizumab.
Secondary	Survival to Hospital Discharge	Hospitalization, up to 4 weeks after tocilizumab administration	This will be defined as the percentage of patients who are discharged in stable condition compared to the percentage of patients who die in the hospital. Patients who are discharged to hospice will be excluded from this calculation.
Secondary	Progression of COVID-19 Pneumonitis	Hospitalization, up to 4 weeks after tocilizumab administration	This will be a binary outcome defined by worsening COVID-19 pneumonitis resulting in transition from clinical Group A or Group B COVID-19 pneumonitis to critical COVID-19 pneumonitis during the course of the patient's COVID-19 infection. This diagnosis will be determined by treating physicians on the basis of worsening pulmonary infiltrates on chest imaging as well as clinical deterioration marked by persistent fever, rising supplemental oxygen requirement, declining PaO2/FiO2 ratio, and the need for intensive care such as mechanical ventilation or vasopressor/inotrope medication(s).
Secondary	Rate of Non-elective Mechanical Ventilation	Hospitalization, up to 4 weeks after tocilizumab administration	This will be a binary outcome defined as worsening COVID-19 disease resulting in the use of non-invasive (BiPap, heated high-flow nasal cannula) or invasive positive pressure ventilation during the course of the patient's COVID-19 infection. For patients admitted to the hospital using non-invasive mechanical ventilation, the utilization of mechanical ventilation will count toward this metric, as well. Calculated as the ratio of the number of patients who require non-invasive or invasive positive pressure ventilation during hospitalization and total number of patients who receive tocilizumab.
Secondary	Duration of Mechanical Ventilation	Hospitalization, up to 4 weeks after tocilizumab administration	This will be a continuous outcome defined by the amount of time between initiation and cessation of mechanical ventilation (invasive and non-invasive).
Secondary	Time to Mechanical Ventilation	Assessed over hospitalization, up to 4 weeks after tocilizumab administration	This will be a continuous outcome defined by the amount of time between tocilizumab dose administration and the initiation of mechanical ventilation. This will be treated as a time-to-event with possible censoring.
Secondary	Rate of Vasopressor/Inotrope Utilization	Hospitalization, up to 4 weeks after tocilizumab administration	This will be a binary outcome defined as utilization of any vasopressor or inotropic medication during the course of the patient's COVID-19 infection. Calculated as the ratio of the number of patients who require vasopressor or inotrope medication during hospitalization and total number of patients who receive tocilizumab.
Secondary	Duration of Vasopressor/Inotrope Utilization	Hospitalization, up to 4 weeks after tocilizumab administration	This will be a continuous outcome defined by the amount of time between initiation of first and cessation of last vasopressor or inotrope medication(s).
Secondary	Time to Vasopressor or Inotropic Utilization	Assessed over hospitalization, up to 4 weeks after tocilizumab administration	This will be a continuous outcome defined by the amount of time between first tocilizumab dose administration and the initiation of vasopressor or inotropic medication(s). This will be treated as a time-to-event with possible censoring.
Secondary	Number of ICU Days	Hospitalization, up to 4 weeks after tocilizumab administration	Number of ICU days is defined as the time period when a patient is admitted to the ICU (defined as the timestamp on the first vital signs collected in an ICU) until they are transferred from the ICU to a non-ICU setting such as a general acute care bed (defined as the timestamp on the first vital signs collected outside an ICU, excepting any "off the floor" vital signs charted from operating rooms or procedure or imaging suites). Death in the ICU will be a competing risk.
Secondary	Duration of Increased Supplemental Oxygen Requirement From Baseline	Assessed over hospitalization, up to 4 weeks after tocilizumab administration	Duration of increased supplemental oxygen requirement from baseline is defined as the time period (number of days) during which the participant requires supplemental oxygen in excess of his/her baseline supplemental oxygen requirement. The supplemental oxygen requirement is defined as the highest liters-per-minute flow of supplemental oxygen required by the patient each day over the course of the hospitalization.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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