Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients

Exclusion Criteria

• •Acute respiratory failure requiring invasive mechanical ventilation or ECMO at enrollment.
• •Systolic Blood Pressure (SBP) \<110 mmHg or heart rate \>120 bpm.
• •Pre-existing heart failure or unstable angina or myocardial infarction in the last month prior to screening.
• •Pre-existing chronic respiratory condition(s).
• •Evidence of acute kidney injury, increase of serum creatinine of ≥1.5 x baseline, or urine output of \<0.5mL/kg/hr sustained for at least 6 hours once volume repleted.
• •Aspartate aminotransferase (AST) ≥2.5 x ULN, alanine aminotransferase (ALT) ≥2.5 x ULN, and/or total bilirubin \>1.5 x ULN, or severe hepatic impairment.
• •Known systemic hypersensitivity to recombinant antibody therapies.
• •Female participant who is pregnant.
• •Participant is expected to transfer to a non-investigative facility from the investigation site and cannot be monitored for compliance with protocol-required safety monitoring procedures.
• •Participants who are currently participating or have participated in another clinical trial within 30 days prior to screening.