Correlated Drug Terms (1)

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	Name (Synonyms)	Correlation
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (1)

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	Name (Synonyms)	Correlation
D007239	Infection NIH	0.06

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Incidence of AEs within 30 days of randomization.

Measure: Incidence of AEs

Time: 30 days

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Description: Mortality within 30 days of randomization.

Measure: Mortality

Time: 30 days

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Description: Cause of death within 30 days of randomization

Measure: Death

Time: 30 days

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Description: Number of ventilator-free days within 60 days of randomization.

Measure: Number of ventilator-free days

Time: 60 days

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Secondary Outcomes

Description: Time from randomization to an improvement of one category using the ordinal scale. The ordinal 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 Not hospitalized, limitation on activities Not hospitalized, no limitations on activities

Measure: Improvement of one category

Time: 30 days

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Description: Change in the 7-point ordinal scale from baseline. The ordinal 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 Not hospitalized, limitation on activities Not hospitalized, no limitations on activities

Measure: 7-point ordinal scale

Time: 30 days

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Description: Change in NEWS from baseline. The following 7 clinical parameters will be assessed: Respiration rate Oxygen saturation Any supplemental oxygen Temperature Systolic blood pressure Heart rate Level of consciousness Measurements within normal ranges are assigned a 0. If the measurement in each category is substantially above or below the normal range, it is given a +1, +2, or +3. The more far off than normal, the bigger the number (in each category). A higher number indicates worse outcome. Each category can be 0-3, except for supplemental oxygen which is only 0-2. The highest value a patient can get is 20.

Measure: NEWS

Time: 30 days

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Description: Time from randomization to discharge or to a NEWS of ≤ 2 maintained for 24 hours, whichever occurs first.

Measure: NEWS of ≤ 2

Time: 30 days

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Description: Change from baseline in Sequential Organ Failure Assessment (SOFA) score on days 8, 15, 22, and 29. System Score for each category is 0-4 with 28 is the maximum score for worst outcome. The following categories are: Respiration Coagulation Liver Cardiovascular Central Nervous System Renal

Measure: Sequential Organ Failure Assessment (SOFA)

Time: days 8, 15, 22, and 29

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Description: Number of days requiring oxygen.

Measure: Oxygen

Time: 30 days

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Description: Duration of hospitalization from randomization.

Measure: Hospitalization

Time: 30 days

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Description: Incidence of SAEs within 30 days of randomization

Measure: Incidence of SAEs

Time: 30 days

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