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

Grifols

Status and phase

Completed

Phase 2

Conditions

COVID-19

Treatments

Biological: Convalescent anti-SARS-CoV-2 MBT Plasma

Drug: Standard Medical Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT04547127

GC2003

2020-001299-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Convalescent anti-SARS-CoV-2 MBT Plasma + SMT

Experimental group

Description:

Participants will receive 2 consecutive transfusions of 200 to 250 milliliters (ml) of ABO-compatible convalescent plasma with each unit of plasma, obtained from the same convalescent donor, which will be administered on Day 1 using standard procedures for administration of fresh frozen plasma. Participants weighing less than 45 kilograms (kg) will receive two transfusions of 10 ml of convalescent plasma per kilogram of body weight with each unit of plasma obtained from the same convalescent donor. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29.

Treatment:

Drug: Standard Medical Treatment

Biological: Convalescent anti-SARS-CoV-2 MBT Plasma

Standard Medical Treatment

Active Comparator group

Description:

Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29.

Treatment:

Drug: Standard Medical Treatment