- subject has been intubated for >72 hours. note: in the event of extubation and re-intubation, the calculation for the number of hours the subject has been intubated begins at the first intubation - require or anticipated need for extracorporeal membrane oxygenation (ecmo) suspected or proven septic shock or shock ; - alanine aminotransferase (alt) or aspartate aminotransferase (ast) is >5 times higher than the upper limit normal range; - severe chronic respiratory disease (e.g., known chronic obstructive pulmonary disease [copd], pulmonary arterial hypertension [pah], idiopathic pulmonary fibrosis [ipf], interstitial lung disease [ild]) requiring supplemental oxygen therapy or mechanical ventilation pre-hospitalization (e.g., prior to covid-19 diagnosis) - use of prohibited medications - participants with severe covid-19 who received convalescent plasma or covid-19 vaccine , or anti-spike (s) sars-cov-2 therapy. - moribund condition in the opinion of the clinical team

- subject has been intubated for >72 hours. note: in the event of extubation and re-intubation, the calculation for the number of hours the subject has been intubated begins at the first intubation - require or anticipated need for extracorporeal membrane oxygenation (ecmo) suspected or proven septic shock or shock ; - alanine aminotransferase (alt) or aspartate aminotransferase (ast) is >5 times higher than the upper limit normal range; - severe chronic respiratory disease (e.g., known chronic obstructive pulmonary disease [copd], pulmonary arterial hypertension [pah], idiopathic pulmonary fibrosis [ipf], interstitial lung disease [ild]) requiring supplemental oxygen therapy or mechanical ventilation pre-hospitalization (e.g., prior to covid-19 diagnosis) - use of prohibited medications - participants with severe covid-19 who received convalescent plasma or covid-19 vaccine , or anti-spike (s) sars-cov-2 therapy. - moribund condition in the opinion of the clinical team