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Eligible subjects (i.e., those meeting the Inclusion / Exclusion criteria) will be enrolled
in one of four cohorts based on the following criteria:
Cohort 1:
All eligible subjects in the PoI who are ≥18 year old subjects with a PIV infection and meet
all of the following criteria:
1.1 Meet criteria for being severely immunocompromised 1.2 Prior to the onset of PIV
infection, had no ongoing need for oxygen therapy due to a chronic respiratory condition
(e.g., COPD, sleep apnea) and are assessed as acutely hypoxemic due to their PIV infection
1.3 At the time of randomization are not on mechanical, bi-level or continuous positive
airway pressure (Bi-PAP or CPAP) ventilation 1.4 Have no known concurrent respiratory viral
coinfection(s)
Cohort 2:
All eligible subjects in the PoI who are ≥18 year old with a PIV infection (including those
with PIV and another SAD-RV) who do not meet one or more of the listed criteria for Cohort 1.
Cohort 3:
All eligible subjects in the PoI who are <18 year old subjects with a PIV infection
(including those with PIV and another concurrent SAD-RV). There is no lower age limit for
this cohort.
Cohort 4:
All eligible subjects in the PoI with a respiratory infection due to any SAD-RV infection
except PIV. Eligible subjects with both PIV and an additional concurrent SAD-RV, will be
enrolled for either Cohorts 2 or 3 depending on their age. There is no lower age limit for
this cohort.
Sub-Study:
Patients with Severe COVID-19
274Patients around the world