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

COVID-19 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547127
• Other study ID #: GC2003
• Secondary ID: 2020-001299-14
• Status: Completed
• Phase: Phase 2
• Start date: April 29, 2020
• Est. completion date: February 4, 2021

Study information

• Verified date: March 2021
• Source: Grifols Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

Biological:
• Convalescent anti-SARS-CoV-2 MBT Plasma
Intravenous infusion.

Drug:
• Standard Medical Treatment
SMT

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona
Spain	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	Hospital Clínico Universitario de Santiago -CHUS	Santiago
Spain	Hospital Universitari Joan XXIII	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-Cause Mortality Rate		Up to Day 29
Secondary	Change from Baseline in National Early Warning Score (NEWS)		Day 1 through Day 29
Secondary	Time to Clinical Response as Assessed by NEWS = 2 Maintained for 24 hours		Day 1 through Day 29
Secondary	Time to Hospital Discharge		Day 1 through Day 29
Secondary	Time to ICU Discharge		Day 1 through Day 29
Secondary	Duration of All Oxygen Use		Day 1 through Day 29
Secondary	Duration of Mechanical Ventilation		Day 1 through Day 29
Secondary	Absolute Value Change from Baseline in Ordinal Scale		Day 1 through Day 29
Secondary	Mean Change from Baseline in Ordinal Scale		Day 1 through Day 29
Secondary	Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale		Day 15 and Day 29