Plasma Therapy of COVID-19 in Severely Ill Patients

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring COVID-19, COVID, Coronavirus, Convalescent plasma Read More

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

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