* participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema; * have spo2 ≤ 93% on room air at sea level or pao2/fio2 \< 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (fda); * require mechanical ventilation or anticipated impending need for mechanical ventilation; * suspected or proven serious bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking part in this study; * have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;

* participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema; * have spo2 ≤ 93% on room air at sea level or pao2/fio2 \< 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (fda); * require mechanical ventilation or anticipated impending need for mechanical ventilation; * suspected or proven serious bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking part in this study; * have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;

participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema; have spo2 ≤ 93% on room air at sea level or pao2/fio2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (fda); require mechanical ventilation or anticipated impending need for mechanical ventilation; suspected or proven serious bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking part in this study; have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;

participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema; have spo2 ≤ 93% on room air at sea level or pao2/fio2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (fda); require mechanical ventilation or anticipated impending need for mechanical ventilation; suspected or proven serious bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking part in this study; have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;