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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Convalescent anti-SARS-CoV-2 MBT Plasma
Standard Medical Treatment
Sponsored by
Instituto Grifols, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital General Universitario de Alicante
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitari de Girona Doctor Josep Trueta
  • Hospital Universitari de Bellvitge
  • Hospital Universitari Arnau de Vilanova
  • Fundación Jimenez Diaz
  • Hospital Clínico San Carlos
  • Hospital Universitario La Paz
  • Hospital Universitario La Princesa
  • Complejo Hospitalario Universitario de Canarias
  • Hospital Clínico Universitario de Santiago -CHUS
  • Hospital Universitari Joan XXIII

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Standard Medical Treatment

Arm 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.

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

Outcomes

Primary Outcome Measures

All-Cause Mortality Rate

Secondary Outcome Measures

Change from Baseline in National Early Warning Score (NEWS)
Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours
Time to Hospital Discharge
Time to ICU Discharge
Duration of All Oxygen Use
Duration of Mechanical Ventilation
Absolute Value Change from Baseline in Ordinal Scale
Mean Change from Baseline in Ordinal Scale
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale

Full Information

First Posted
September 10, 2020
Last Updated
March 2, 2021
Sponsor
Instituto Grifols, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04547127
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Grifols, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convalescent anti-SARS-CoV-2 MBT Plasma + SMT
Arm Type
Experimental
Arm 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.
Arm Title
Standard Medical Treatment
Arm Type
Active Comparator
Arm Description
Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29.
Intervention Type
Biological
Intervention Name(s)
Convalescent anti-SARS-CoV-2 MBT Plasma
Intervention Description
Intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Standard Medical Treatment
Intervention Description
SMT
Primary Outcome Measure Information:
Title
All-Cause Mortality Rate
Time Frame
Up to Day 29
Secondary Outcome Measure Information:
Title
Change from Baseline in National Early Warning Score (NEWS)
Time Frame
Day 1 through Day 29
Title
Time to Clinical Response as Assessed by NEWS ≤ 2 Maintained for 24 hours
Time Frame
Day 1 through Day 29
Title
Time to Hospital Discharge
Time Frame
Day 1 through Day 29
Title
Time to ICU Discharge
Time Frame
Day 1 through Day 29
Title
Duration of All Oxygen Use
Time Frame
Day 1 through Day 29
Title
Duration of Mechanical Ventilation
Time Frame
Day 1 through Day 29
Title
Absolute Value Change from Baseline in Ordinal Scale
Time Frame
Day 1 through Day 29
Title
Mean Change from Baseline in Ordinal Scale
Time Frame
Day 1 through Day 29
Title
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Time Frame
Day 15 and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Radiographic infiltrates by imaging (chest x-ray, computerized tomography [CT] scan, etc.), and 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.
Facility Information:
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari de Girona Doctor Josep Trueta
City
Girona
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
Country
Spain
Facility Name
Fundación Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Canarias
City
Santa Cruz De Tenerife
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago -CHUS
City
Santiago
Country
Spain
Facility Name
Hospital Universitari Joan XXIII
City
Tarragona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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