Correlated Drug Terms (3)

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	Name (Synonyms)	Correlation
drug1604	Nitric Oxide Wiki	0.35
drug1086	Hydroxychloroquine Wiki	0.07
drug1822	Placebo Wiki	0.04

Correlated MeSH Terms (8)

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	Name (Synonyms)	Correlation
D055371	Acute Lung Injury NIH	0.14
D012127	Respiratory Distress Syndrome, Newborn NIH	0.14
D012128	Respiratory Distress Syndrome, Adult NIH	0.12
D011024	Pneumonia, Viral NIH	0.09
D045169	Severe Acute Respiratory Syndrome NIH	0.07
D003141	Communicable Diseases NIH	0.06
D018352	Coronavirus Infections NIH	0.06
D007239	Infection NIH	0.04

Correlated HPO Terms (0)

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	Name (Synonyms)	Correlation

Primary Outcomes

Description: Respiratory failure, is defined based on resource utilization of any of the following modalities: Endotracheal intubation and mechanical ventilation Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation or continuous positive airway pressure Extracorporeal membrane oxygenation

Measure: Subject alive and free of respiratory failure

Time: Day 14

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Secondary Outcomes

Measure: Proportion of subjects alive and free of respiratory failure

Time: Day 28

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Measure: Percent change from baseline in CRP

Time: Days 3, 5, 7, 10, 14, 28

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Measure: Change from baseline in ferritin

Time: Days 3, 5, 7, 10, 14, 28

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Measure: Chnage from baseline in absolute lymphocyte counts

Time: Days 3, 5, 7, 10, 14, 28

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Measure: All cause mortality

Time: Day 90

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Measure: Proportion of subjects alive and discharged from ICU

Time: Days 14 and 28

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Measure: Time from randomization to first occurrence of respiratory failure or death on study due to any cause

Time: Up to 28 days after randomization

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Measure: Number of days alive and free of respiratory failure

Time: To 28 days after randomization

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Measure: Number of days with respiratory failure

Time: to 28 days after randomization

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Measure: Number of days hospitalized

Time: To 28 days after randomization

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Measure: Number of days in ICU (length of stay)

Time: To 90 days after randomization

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Measure: Number of days alive outside of hospital

Time: To 28 days after randomization

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Measure: Number of days alive outside of hospital

Time: To 90 days after randomization

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Measure: Relative change from baseline in oxygenation index (PaO2/FiO2)

Time: To Day 5

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Description: Type, frequency, severity, and relationship to study treatment of any TEAEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study treatment.

Measure: Occurrence of Adverse Events and Serious Adverse Events

Time: 28 days after last dose

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Description: Peak Plasma Concentration (Cmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Cmax)

Time: 28 days after last dose

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Description: Time to Maximum Concentration (Tmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Tmax)

Time: 28 days after last dose

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Description: Area under the plasma concentration versus time curve (AUC)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (AUC)

Time: 28 days after last dose

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Primary Outcomes

Description: Type, frequency, severity, and relationship to study treatment of any TEAEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study treatment.

Measure: Occurrence of Adverse Events and Serious Adverse Events

Time: Day 14

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Description: Respiratory failure, is defined based on resource utilization of any of the following modalities: Endotracheal intubation and mechanical ventilation Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5) Noninvasive positive pressure ventilation or continuous positive airway pressure Extracorporeal membrane oxygenation

Measure: Subject alive and free of respiratory failure

Time: Day 28

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Secondary Outcomes

Measure: Proportion of subjects alive and free of respiratory failure

Time: Day 28

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Measure: Percent change from baseline in CRP

Time: Days 3, 5, 7, 10, 14, 28

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Measure: Change from baseline in ferritin

Time: Days 3, 5, 7, 10, 14, 28

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Measure: Change from baseline in absolute lymphocyte counts

Time: Days 3, 5, 7, 10, 14, 28

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Measure: All cause mortality

Time: Day 90

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Measure: Proportion of subjects alive and discharged from ICU

Time: Days 14 and 28

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Measure: Time from randomization to first occurrence of respiratory failure or death on study due to any cause

Time: Up to 28 days after randomization

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Measure: Number of days alive and free of respiratory failure

Time: Up to 28 days after randomization

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Measure: Number of days with respiratory failure

Time: Up to 28 days after randomization

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Measure: Number of days hospitalized

Time: Up to 28 days after randomization

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Measure: Number of days in ICU (length of stay)

Time: Up to 90 days after randomization

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Measure: Number of days alive outside of hospital

Time: Up to 28 days after randomization

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Measure: Number of days alive outside of hospital

Time: Up to 90 days after randomization

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Measure: Relative change from baseline in oxygenation index (SpO2/FiO2)

Time: Days 3, 5, 7, and 10

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Measure: Time to clinical improvement of at least 2 points (from randomization) on a 9-point category ordinal scale

Time: Up to 28 days after randomization

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Measure: Time to SpO2 > 94% on room air

Time: Up to 28 days after randomization

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Description: Plasma concentrations of acalabrutinib and ACP-5862

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862

Time: Days 3 and 7

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