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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Intravenous infusion.
SMT
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
All-Cause Mortality Rate
Time frame: Up to Day 29
Change from Baseline in National Early Warning Score (NEWS)
Time frame: Day 1 through Day 29
Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours
Time frame: Day 1 through Day 29
Time to Hospital Discharge
Time frame: Day 1 through Day 29
Time to ICU Discharge
Time frame: Day 1 through Day 29
Duration of All Oxygen Use
Time frame: Day 1 through Day 29
Duration of Mechanical Ventilation
Time frame: Day 1 through Day 29
Absolute Value Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Mean Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Time frame: Day 15 and Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Fundación Jimenez Diaz
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario La Princesa
Madrid, Spain
Complejo Hospitalario Universitario de Canarias
Santa Cruz de Tenerife, Spain
...and 2 more locations