Correlated Drug Terms (2)

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	Name (Synonyms)	Correlation
drug1687	Online Survey Wiki	0.50
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (2)

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	Name (Synonyms)	Correlation
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29

Measure: Proportion of subjects alive and free of respiratory failure

Time: 29 days

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Description: Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29

Measure: Proportion of subjects discharged home alive

Time: 29 days

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Description: Proportion of patients experiencing AEs

Measure: Treatment-emergent adverse events (AEs)

Time: 29 days

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Secondary Outcomes

Description: Clinical status at Day 29 on a 7-point ordinal scale, where 1 = not hospitalized with resumption of normal activities; 2 = not hospitalized but unable to resume normal activities; 3 = hospitalized but not requiring supplemental oxygen; 4 = hospitalized and requiring supplemental oxygen; 5 = hospitalized and requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6 = hospitalized and requiring invasive mechanical ventilation and/or extra-corporeal membrane oxygenation; and 7 = death

Measure: Clinical status

Time: 29 days

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Description: Time (days) to improvement of 2 points on 7-point ordinal clinical scale

Measure: Time to improvement

Time: 29 days

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Description: Proportion of patients who require mechanical ventilation

Measure: Incidence of mechanical ventilation

Time: 29 days

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Description: Ventilator-free days to Day 29

Measure: Ventilator-free days

Time: 29 days

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Description: Proportion of patients who require ICU admission

Measure: Incidence of Intensive Care Unit (ICU) admission

Time: 29 days

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Description: Duration (days) of ICU stay

Measure: Duration of ICU stay

Time: 29 days

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Description: Time (days) to hospital discharge

Measure: Time to hospital discharge

Time: 29 days

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Description: Duration (days) of need for supplemental oxygen

Measure: Duration of need for supplemental oxygen

Time: 29 days

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Description: Time (days) to virus negativity by RT-PCR, defined as absence of SARS CoV 2 on 2 consecutive days of sampling

Measure: Time to virus negativity

Time: 29 days

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Description: SARS-CoV-2 viral load (number of copies) by quantitative RT-PCR

Measure: SARS-CoV-2 viral load

Time: 29 days

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Description: Proportion of patients experiencing AEs leading to early discontinuation of trial treatment

Measure: AEs leading to withdrawal

Time: 29 days

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Description: Proportion of patients experiencing SAEs

Measure: Treatment-emergent serious AEs (SAEs)

Time: 29 days

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Description: Proportion of patients experiencing treatment-emergent changes in clinical laboratory parameters or ECGs

Measure: Treatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs)

Time: 29 days

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Description: Proportion of patients who meet study safety-related stopping rules

Measure: Incidence of meeting safety-related stopping rules

Time: 29 days

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Description: Plasma concentrations over time of piclidenoson

Measure: Pharmacokinetics of piclidenoson in this patient population

Time: 5 days

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