Adverse event reporting
critically ill, pneumothorax, respiratory and cardiovascular deteriorations, FiOSustained deterioration, respiratory deteriorations, bronchospasm
CRITICALLY ILL, PULMONARY HAEMORRHAGE, PNEUMOTHORAX, LOBAR COLLAPSE, ADVERSE EVENTS, EVENT, EVENTS, BRONCHOSPASM, MULTI-ORGAN FAILURE
COVID-19 participants enrolled in this study were already critically ill with multiple COVID-19 related medical issues and were at risk of ongoing clinical deterioration and multi-organ failure. It was expected that many of these patients would experience events during their clinical pathway, but these were not reported unless the event was considered by the investigator to be associated with the study drug or delivery.Any of the following pre-specified respiratory and cardiovascular deteriorations or adverse events occurring during nebulization and occurring within 48 h were recorded.Increase in oxygen (FiOSustained deterioration in pulmonary ventilation variables (> 10% increase in peak or mean airway pressures or decrease in tidal volume).Any episode of new cardiac arrhythmiaSustained increase in heart rate of > 20%Sustained reduction in mean arterial blood pressure (MAP) of > 10% or an increase in the vasopressor dose of Norepinephrine (0.1mcg/kg/min), epinephrine (0.1 mcg/kg/min) or the use of additional inotropes (dopamine/dobutamine/milrinone) or vasopressors (vasopressin/terlipressin/phenylephrine).New bronchospasm requiring treatment.Other respiratory deteriorations: pneumothorax (evidence on imaging), pulmonary haemorrhage (clinical) and acute lobar collapse (evidence on imaging), including transfer to tertiary hospital for ECMO were collected.