A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)

Inclusion criteria

• Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the intensive care unit (ICU) for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission.
• Subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides informed consent (ICF) prior to initiation of any study procedures.
• Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen during the current hospital admission prior to randomization.
• Illness (symptoms) of any duration, and the following:

• Radiographic infiltrates by imaging (chest x-ray, computerized tomography [CT] scan, etc.), and
• Requiring mechanical ventilation and/or supplemental oxygen
• Subjects with no limitation of therapeutic effort (decision on the status and future of the subject).
• Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.

Exclusion criteria

• Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
• The subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product or methylene blue.
• A medical condition in which the infusion of additional fluid is contraindicated.
• Shock unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.