Plasma Therapy of COVID-19 in Severely Ill Patients

There are few effective therapies for coronavirus disease 2019 (COVID-19) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS-CoV). Small clinical trials and observational studies of CP therapy in patients with COVID-19 have suggested a possible clinical benefit.

Inclusion criteria

• Willing and able to provide written informed consent prior to performing study procedures or have a legally authorized representative available to do so.
• Age ≥18 years
• Evidence of SARS-CoV-2 infection by PCR test of naso-/oro-pharyngeal swab or tracheal aspirate sample within 14 days of randomization
• Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation at screening
• Evidence of infiltrates on chest radiography
• Females of childbearing age and males, must be willing to practice an effective contraceptive method or remain abstinent during the study period.

Exclusion criteria

• Participation in another clinical trial of anti-viral agent(s) for COVID-19
• Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 <24 hours prior to study drug administration [1]
• Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days
• Severe multi-organ failure
• History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria
• Known Immunoglobulin A (IgA) deficiency
• Females who are pregnant

• Use of remdesivir as treatment for COVID-19 is permitted.