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

A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) With Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit (ICU)

The purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the intensive care unit (ICU) through Day 29.

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.