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:

1. Radiographic infiltrates by imaging (chest x-ray, computerized tomography [CT]
scan, etc.), and

2. 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.