Correlated Drug Terms (2)

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	Name (Synonyms)	Correlation
drug1923	Prone positioning Wiki	0.58
drug1822	Placebo Wiki	0.06

Correlated MeSH Terms (3)

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	Name (Synonyms)	Correlation
D000860	Hypoxia NIH	0.23
D045169	Severe Acute Respiratory Syndrome NIH	0.05
D018352	Coronavirus Infections NIH	0.04

Correlated HPO Terms (1)

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	Name (Synonyms)	Correlation
HP:0012418	Hypoxemia HPO	0.23

Primary Outcomes

Description: a. Efficacy will be measured by the average between group difference on a 6-point, ordinal, severity rating scale at Day 15. The severity ratings are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized

Measure: To evaluate efficacy of vazegepant (BHV-3500) compared with placebo in subjects hospitalized with COVID-19 infection requiring supplemental oxygen, using a six-point rating scale at Day 15. .

Time: Baseline to Day 15

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Secondary Outcomes

Measure: The proportion of unique subjects alive and off of oxygen. These are subjects in categories 5 or 6 of the 6-point ordinal scale being used as the primary endpoint.

Time: Baseline to Day 29

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Measure: A subject requiring initiation of invasive mechanical ventilation, non-invasive ventilation, or a high flow nasal cannula is a subject that has any eCRF showing the use of any such device on any day.

Time: Baseline to Day 60

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Measure: The proportion of unique subjects admitted to an ICU verse those not admitted.

Time: Baseline to Day 60

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Measure: Subjects are alive and respiratory-failure free if they are categorized as being in categories 3, 4, 5 or 6 of the 6-point ordinal scale being used as the primary endpoint.

Time: Baseline to Day 60

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Measure: Subjects are alive and free of either invasive mechanical ventilation or non-invasive ventilation if they are categorized as being in categories 4, 5 or 6 of the 6-point ordinal scale being used as the primary endpoint.

Time: Baseline to Day 60

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Measure: Efficacy on Day 29 will be evaluated using the same 6-point severity scales that is used at Day 15.

Time: Baseline at Day 15 and at Day 29

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Measure: Time to improvement of one category on the 6-point severity scale will be determined as the number of days from baseline to the first day that an eCRF indicates a one category improvement in the scale.

Time: Baseline to Day 60

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Measure: A 48-hour improvement in SpO2/FiO2 ratio consists of two consecutive days where the case report forms show a clinically meaningful increase from baseline.

Time: Baseline to Day 60

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Measure: The time to improvement in the in the NEWS2 scale will be determined as the number of days from baseline to the first eCRF that shows an improvement.

Time: Baseline to Day 29

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Measure: A score < 2 for 24 hours on the NEWS2 scale consists of a day where all of the reported NEWS2 scores are < 2.

Time: Baseline to Day 29

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Measure: The change in NEWS2 scores will be determined as the change from baseline at Day 15 and at Day 29.

Time: Baseline at Day 15 and at Day 29.

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Measure: The proportion of unique subjects alive and off of oxygen.

Time: Baseline to Day 60

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Measure: The proportion of subjects discharged to home on supplemental oxygen will determined from the unique number of subjects have eCRF pages indicating they were discharged to home while still on supplemental oxygen.

Time: Baseline to Day 60

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Measure: A day with a resting respiratory rate > 24 is a day in which all eCRFs collected for a subject indicate observed respiratory rates > 24 breaths per minute.

Time: Baseline to Day 29

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Measure: A day with supplemental oxygen is one in which any case report form collected on that day indicates the use of any amount of supplemental oxygen.

Time: Baseline to Day 29

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Measure: Time to saturation greater than or equal to 90% on room air is measured by the number of days from baseline to the first day on which an eCRF indicates saturation greater than or equal to 90% without any supplemental oxygenation.

Time: Baseline to Day 60

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Measure: A ventilator free day is a day in which all of the eCRFs collected indicate that the subject was not using a ventilator.

Time: Baseline to Day 29

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Measure: SOFA scores will be determined from eCRFs. Values will be determined for subjects at admission to an ICU and for all subjects still in an ICU at the end of the study (Day 29).

Time: Baseline to Day 29

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Measure: The number of days of hospitalization will be determined from eCRFs. A hospitalization day is any day that it is shown that a subject spent at least spent part of the day in a hospital.

Time: First day of hospital admission to discharge from hospital (evaluated from Baseline to Day 60)

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Measure: Time to fever resolution, without antipyretics, during two contiguous days .

Time: Screening to 48 hours fever free

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Measure: The number of deaths, SAEs, severe AEs and Grade 3 or 4 laboratory abnormalities will be tabulated as the number of unique subjects meeting those criteria.

Time: Screening to Day 60

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Measure: The incidence of severe or life-threatening bacterial, invasive fungal, or opportunistic infections will be tabulated as the number of unique subjects, reported in eCRFs, as having these conditions at any point in the study

Time: Screening to day 60

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Measure: The incidence of intranasal administration reactions will be tabulated, from eCRFs, as the number of unique subjects having such a condition at any point in the study.

Time: Baseline to Day 60

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Measure: The proportion of subjects who develop significant renal disease.

Time: Baseline to Day 60

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