Ordinal Outcomes for Early Futility Assessments: Two ordinal outcomes will be used to assess futility after approximately 300 patientes have been enrolled. Both outcomes are assessed 5 days after randomization (Day 5), the participant’s highest (i.e. most severe) observed score on Day 5 is used. The first ordinal outcome, referred to as the “pulmonary” ordinal outcome, is primarily defined based on oxygen requirements. The second ordinal outcome, referred to as “pulmonary+,” also assessed at Day 5, captures extra-pulmonary complications as well as respiratory dysfunction. Primary and Secondary Outcomes to Evaluate Efficacy and Safety: The primary endpoint is time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol.

Ordinal Outcomes for Early Futility Assessments: Two ordinal outcomes will be used to assess futility after approximately 300 patientes have been enrolled. Both outcomes are assessed 5 days after randomization (Day 5), the participant’s highest (i.e. most severe) observed score on Day 5 is used. The first ordinal outcome, referred to as the “pulmonary” ordinal outcome, is primarily defined based on oxygen requirements. The second ordinal outcome, referred to as “pulmonary+,” also assessed at Day 5, captures extra-pulmonary complications as well as respiratory dysfunction. Primary and Secondary Outcomes to Evaluate Efficacy and Safety: The primary endpoint is time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol.