Clinical trial NCT04547127: A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Coronavirus Disease
Severe acute respiratory syndrome coronavirus 2
SARS-CoV-2
Lead sponsor: Grifols Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: All-Cause Mortality Rate
timeFrame: Up to Day 29
Secondary outcomes:
measure: Change from Baseline in National Early Warning Score (NEWS)
timeFrame: Day 1 through Day 29
measure: Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours
timeFrame: Day 1 through Day 29
measure: Time to Hospital Discharge
timeFrame: Day 1 through Day 29
measure: Time to ICU Discharge
timeFrame: Day 1 through Day 29
measure: Duration of All Oxygen Use
timeFrame: Day 1 through Day 29
measure: Duration of Mechanical Ventilation
timeFrame: Day 1 through Day 29
measure: Absolute Value Change from Baseline in Ordinal Scale
timeFrame: Day 1 through Day 29
measure: Mean Change from Baseline in Ordinal Scale
timeFrame: Day 1 through Day 29
measure: Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
timeFrame: Day 15 and Day 29
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Santa Cruz De Tenerife
country: Spain
facility: Complejo Hospitalario Universitario de Canarias
city: Santiago
country: Spain
facility: Hospital Clínico Universitario de Santiago -CHUS
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII
Study officials:
References: