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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-29

Study Completion Date

2021-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Plasma for Early Treatment in Non-hospitalised Mild or Moderate COVID-19 Patients

NCT04621123

SARS-CoV-2 Infection Safety and Efficacy

COMPLETED PHASE2

Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease

NCT04542967

Severe COVID-19 Disease

COMPLETED PHASE2

Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma

NCT04803370

Covid19

COMPLETED NA

Convalescent Plasma for the Treatment of COVID-19 (Coronavirus Disease 2019)

NCT04554992

Covid19

UNKNOWN PHASE1

Convalescent Plasma in Hospitalized COVID-19 Patients

NCT05157165

COVID-19

NO_LONGER_AVAILABLE

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type EXPERIMENTAL

Convalescent anti-SARS-CoV-2 MBT Plasma

Intervention Type BIOLOGICAL

Intravenous infusion.

Standard Medical Treatment

Intervention Type DRUG

SMT

Standard Medical Treatment

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

Group Type ACTIVE_COMPARATOR

Standard Medical Treatment

Intervention Type DRUG

SMT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Convalescent anti-SARS-CoV-2 MBT Plasma

Intravenous infusion.

Intervention Type BIOLOGICAL

Standard Medical Treatment

SMT

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No