COVID-19
Conditions
Keywords
Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2
Brief summary
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.
Interventions
BIOLOGICALConvalescent anti-SARS-CoV-2 MBT Plasma
Intravenous infusion.
DRUGStandard Medical Treatment
SMT
Sponsors
Instituto Grifols, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-Cause Mortality Rate | Up to Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours | Day 1 through Day 29 |
| Time to Hospital Discharge | Day 1 through Day 29 |
| Time to ICU Discharge | Day 1 through Day 29 |
| Duration of All Oxygen Use | Day 1 through Day 29 |
| Change from Baseline in National Early Warning Score (NEWS) | Day 1 through Day 29 |
| Absolute Value Change from Baseline in Ordinal Scale | Day 1 through Day 29 |
| Mean Change from Baseline in Ordinal Scale | Day 1 through Day 29 |
| Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale | Day 15 and Day 29 |
| Duration of Mechanical Ventilation | Day 1 through Day 29 |
Countries
Spain
Outcome results
None listed