Correlated Drug Terms (4)

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	Name (Synonyms)	Correlation
drug164	Baricitinib (janus kinase inhibitor) Wiki	1.00
drug631	Hydroxychloroquine sulfate Wiki	0.71
drug760	Lopinavir/ritonavir Wiki	0.30
drug1016	Placebo Wiki	0.08

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D018352	Coronavirus Infections NIH	0.05

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: The primary objective of this study is to determine whether tofacitinib improves the clinical outcomes of patients with moderate SARS-CoV-2 infection as determined by the primary outcome measure: Proportion of subjects alive and not needing any form of mechanical ventilation, high flow oxygen, or ECMO by day 14.

Measure: Disease Severity

Time: 14 days

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Secondary Outcomes

Description: Clinical improvement as measured by NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities) at day 14. The scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities.

Measure: Clinical improvement

Time: 14 days

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Description: Clinical improvement as measured by NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities) (days 3 through day 14): The scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities.

Measure: Clinical improvement

Time: Up to 14 days

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Description: Time to recovery [ Time Frame: Day 1 through Day 14] (Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities)

Measure: Time to recovery

Time: Up to 14 days

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Description: Time to clinical improvement (defined as a 2-point increase on the NIAID 8-point ordinal scale (i.e., 1 = death and 8 = Not hospitalized, no limitations on activities). The scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities.

Measure: Time to clinical improvement

Time: 30 days

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Description: Clinical status on the NIAID 8-point ordinal scale at day 30 The scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities.

Measure: Clinical status

Time: 30 Days

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Description: Clinical status on the NIAID 8-point ordinal scale at day 60 The scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities.

Measure: Clinical status

Time: 60 Days

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Description: Clinical status on the NIAID 8-point ordinal scale at day 90 The scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities.

Measure: Clinical status

Time: 90 Days

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Description: Mortality rate at day 30

Measure: Mortality

Time: 30 Days

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Description: Mortality rate at day 60

Measure: Mortality

Time: 60 Days

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Description: Mortality rate at day 90

Measure: Mortality

Time: 90 Days

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Description: Proportion of patients requiring mechanical ventilatory support.

Measure: Mechanical Ventilatory Support

Time: Up to 14 Days

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Description: Duration of invasive mechanical ventilation (days).

Measure: Mechanical Ventilatory Support Duration

Time: Up to 14 Days

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Description: Invasive mechanical ventilation free days.

Measure: Freedom from mechanical ventilation

Time: Up to 14 Days

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Description: Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Measure: Adverse events

Time: Up to 14 days

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Description: Did the patient receive an intervention with additional immunomodulatory agent (i.e. IL-6 targeting therapy)? (y/n)

Measure: Additional intervention

Time: Up to 14 days

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Description: Change in SARS-CoV-2 viral titers during intervention.

Measure: Viral titer

Time: Up to 14 days

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