Correlated Drug Terms (2)

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	Name (Synonyms)	Correlation
drug2620	VPM1002 Wiki	0.58
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (2)

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	Name (Synonyms)	Correlation
D003141	Communicable Diseases NIH	0.09
D007239	Infection NIH	0.06

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Days alive and free of any episodes of acute respiratory failure through Day 22 defined by need for high-flow nasal cannula, noninvasive positive-pressure ventilation, endotracheal intubation and mechanical ventilation, and extracorporeal membrane oxygenation

Measure: Acute respiratory failure

Time: Day 1-22

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Secondary Outcomes

Description: Defined as time to the first day that a subject is in categories 6, 7, or 8 on the Eight-Point Ordinal Scale. The Eight-Point Ordinal Scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen—requiring ongoing medical care (COVID-19-related or otherwise); 6) Hospitalized, not requiring supplemental oxygen—no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: Time to clinical improvement

Time: Day 1-29

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Description: Proportion of patients alive and free of any episode of acute respiratory failure through Days 8, 15, 22, and 29

Measure: Acute respiratory failure

Time: Days 1-8, 1-15, 1-22, 1-29

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Description: Proportion of patients alive and free of invasive mechanical ventilation through Days 8, 15, 22, and 29

Measure: Invasive mechanical ventilation

Time: Days 1-8, 1-15, 1-22, 1-29

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Description: Days alive and free of acute respiratory failure through Days 15 and 29

Measure: Acute respiratory failure

Time: Days 1-15 and 1-29

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Description: Days alive and free of invasive mechanical ventilation through Days 15, 22, and 29

Measure: Invasive mechanical ventilation

Time: Days 1-15, 1-22, 1-29

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Description: Days alive and hospitalized through Day 29

Measure: Hospitalization

Time: Days 1-29

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Description: Change in Sequential Organ Failure Assessment (SOFA) score (range 0 [best] to 24 [worst]) from baseline to Day 8, Day 15, and Day 22

Measure: Sequential Organ Failure Assessment

Time: Days 1-8, 1-15, 1-22

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Description: Worst SOFA score from baseline to Day 22

Measure: Sequential Organ Failure Assessment

Time: Days 1-22

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Description: Proportion of patients alive and discharged from the hospital at Days 15 and 29.

Measure: Hospitalization

Time: Days 1-15, 1-29

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Description: Mean change in the eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29

Measure: Ordinal Scale

Time: Days 1-29

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Description: Time to improvement in one category from baseline using an eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29.

Measure: Time to clinical improvement

Time: Days 1-29

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Description: Time to improvement in two categories from baseline using an eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29.

Measure: Time to clinical improvment

Time: Days 1-29

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Description: Time to recovery through Day 29. Day of recovery is defined as the first day on which the subject satisfies one of categories 6-8 from the ordinal scale.

Measure: Time to recovery

Time: Days 1-29

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Description: Change in C-reactive protein in blood on Days 4 and 8 compared to baseline (from normal < 10 mg/L [normal] to >10 mg/L [worse])

Measure: Change in C-reactive protein

Time: Day 4 compared to baseline; Day 8 compared to baseline

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Description: Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events

Measure: Adverse events

Time: Days 1-60

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Description: Cumulative incidence of serious adverse events

Measure: Serious adverse events

Time: Days 1-60

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