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

NCT04547127 | Completed Phase 2

• 2 other identifiers: GC20032020-001299-14
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 12

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.

Conditions

COVID-19

Keywords

Coronavirus Disease; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality Rate

  Up to Day 29

Secondary Outcomes (9)

• Change from Baseline in National Early Warning Score (NEWS)

  Day 1 through Day 29

• 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

Study Arms (2)

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

EXPERIMENTAL

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.

Biological: Convalescent anti-SARS-CoV-2 MBT Plasma; Drug: Standard Medical Treatment

Standard Medical Treatment

ACTIVE COMPARATOR

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

Drug: Standard Medical Treatment

Interventions

Convalescent anti-SARS-CoV-2 MBT Plasma BIOLOGICAL

Intravenous infusion.

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

Standard Medical Treatment DRUG

SMT

Convalescent anti-SARS-CoV-2 MBT Plasma + SMT; Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Grifols, S.A.: lead

Study Sites (12)

Hospital General Universitario de Alicante

Alicante, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Location

Fundación Jimenez Diaz

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Complejo Hospitalario Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Clínico Universitario de Santiago -CHUS

Santiago, Spain

Location

Hospital Universitari Joan XXIII

Tarragona, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 14, 2020
• Study Start: April 29, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12)