Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19

May 30, 2020 updated by: National Blood Center Foundation, Hemolife

Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19

Convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. It has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as Influenza H1N1, H5N1, H7N9, Ebola, MERS, SARS-CoV1, and even SARS-Cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. One of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. Then this plasma will be inactivated by riboflavin and UV based photochemical treatment (Mirasol technology - Terumo BCT®), in order to add more transfusion security to the procedure. Finally, it will be transfused to CoViD-19 patients hospitalized in any of the participating clinics. There are currently no reported significant adverse events associated with this therapy. Have been published two serial cases reports,more evidence is necessary to standardize the treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Colombia
      • Bogotá, Colombia
        • Clínica Corpas
      • Facatativa, Colombia
        • E.S.E Hospital San Rafael Facatativa
      • Popayán, Colombia
        • Clínica la Estancia
    • Antioquía
      • Medellín, Antioquía, Colombia, 0500
        • Clínica Antioquía
      • Medellín, Antioquía, Colombia, 0500
        • Clínica Sagrado Corazón
      • Medellín, Antioquía, Colombia, 0500
        • IPS Universitaria
      • Medellín, Antioquía, Colombia, 0500
        • Universidad de Antioquia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 1101
        • National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
    • Risaralda
      • Pereira, Risaralda, Colombia
        • Clínica Rosales
    • Valle
      • Cali, Valle, Colombia
        • Clinica Nuestra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years old
  • Confirmed laboratory diagnosis for qRT-PCR to SARS-CoV-2
  • Meet any of the following medical criteria (Defined by WHO): Be currently hospitalized with: Pneumonia, Severe pneumonia, Acute Respiratory Distress Syndrome (moderate or severe), Sepsis or Septic shock
  • The patient, or his representative, must sign an informed consent

Exclusion Criteria:

  • Participate in another clinical trial for CoViD- 19
  • History of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets),
  • History of allergic reaction due to IgA deficiency
  • Allergic reaction to sodium citrate or riboflavin (vitamin B2)
  • History of immunosuppression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Convalescent plasma+Support treatment selected by the hospital
Participants will receive two doses of ABO - Rh compatible inactivated convalescent plasma, each one of 200 mililiters (mL), with a 24-hour interval via transfusion, for a final volume of 400 mL, meanwhile they continue to receive the supportive treatment chosen by the hospitals, according to each institutional protocol.
Drug: Inactivated convalescent plasma

Day 0: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma, Start of support treatment selected by medical staff according to each institutional protocol

Day 1: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma

Other Names:
  • Inactivated convalescent plasma SARS-Cov-2 + Support treatment
Drug: Support treatment
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
Other Names:
  • Support treatment under medical decision
Active Comparator: Support treatment selected by the hospital
The best support treatment selected by the hospital, according to each institutional protocol. Due to the ongoing development of knowledge of pathophysiology and scientific evidence of the available alternatives, it will be selected at the time of treatment.
Drug: Support treatment
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
Other Names:
  • Support treatment under medical decision

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
Time Frame: Over a period of 28 days
To assess the efficacy in reducing mortality in CoViD-19 patients treated with inactivated convalescent plasma together with the support treatment selected by the respective hospital
Over a period of 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical evolution
Time Frame: Over a period of 28 days
Number of Participants with resolution of fever (<38ºC temperature)
Over a period of 28 days
Clinical evolution by seven-parameter ordinal scale
Time Frame: 3, 7, 14 and 28 days
The clinical improvement will be established with a two-point improvement within this seven categories (recommended by World Organization Health-WHO): 1) Not hospitalized, with resumption of normal activities 2) Not hospitalized, but unable to resume normal activities 3) Hospitalized that does not require supplemental oxygen 4) Hospitalized requiring supplemental oxygen 5) Hospitalized requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both 6) Hospitalized requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both 7) death
3, 7, 14 and 28 days
Multi-organ failure progression
Time Frame: 3, 7, 14 and 28 days
Evolution by SOFA (Sequential Organ Failure Assessment), The range is between 0 and 24 points, with the highest scores being indicators of a more serious illness
3, 7, 14 and 28 days
Change in hemoglobin concentration
Time Frame: 3, 7, 14 and 28 days
Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in blood cell count
Time Frame: 3, 7, 14 and 28 days
Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in serum creatinine level
Time Frame: 3, 7, 14 and 28 days
Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in aspartate aminotransferase level
Time Frame: 3, 7, 14 and 28 days
Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in alanin aminotransferase level
Time Frame: 3, 7, 14 and 28 days
Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in bilirubin level
Time Frame: 3, 7, 14 and 28 days
Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in lactate dehydrogenase level
Time Frame: 3, 7, 14 and 28 days
Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in creatine kinase level
Time Frame: 3, 7, 14 and 28 days
Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in creatine kinase MB level
Time Frame: 3, 7, 14 and 28 days
Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in C reactive protein concentration
Time Frame: 3, 7, 14 and 28 days
Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L
3, 7, 14 and 28 days
Change in D Dimer concentration
Time Frame: 3, 7, 14 and 28 days
Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in Procalcitonin concentration
Time Frame: 3, 7, 14 and 28 days
Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Change in IL6 level
Time Frame: 3, 7, 14 and 28 days
Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment
3, 7, 14 and 28 days
Radiography imaging
Time Frame: Over a period of 60 days
Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)
Over a period of 60 days
Tomography imaging
Time Frame: Over a period of 60 days
Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Over a period of 60 days
Assessment of oxygenation
Time Frame: 3, 7, 14 and 28 days
Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio
3, 7, 14 and 28 days
Viral Load
Time Frame: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
Viral Load Quantification
0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
Antibody titer
Time Frame: Day 0, Day 3 and Day 7
Neutralizing antibody anti SARS-CoV-2 titer evolution
Day 0, Day 3 and Day 7
Oxygen-free days through Day 60
Time Frame: Until hospital discharge or a maximum of 60 days whichever comes first
Number of days without use of Oxygen
Until hospital discharge or a maximum of 60 days whichever comes first
Mechanical ventilation-free days through Day 28
Time Frame: Until hospital discharge or a maximum of 28 days whichever comes first
Number of days without use of mechanical ventilation
Until hospital discharge or a maximum of 28 days whichever comes first
Intensive Care Unit (ICU)-free days through Day 28
Time Frame: Until hospital discharge or a maximum of 28 days whichever comes first
Time outside of ICU, in days
Until hospital discharge or a maximum of 28 days whichever comes first
Hospital-free days through Day 60
Time Frame: Until hospital discharge or a maximum of 60 days whichever comes first
Time outside of the hospital, in days
Until hospital discharge or a maximum of 60 days whichever comes first

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 28 days
Occurrence of adverse events during inactivated convalescent plasma transfusion, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Blood Center Foundation, Hemolife

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrés F Zuluaga, MD, MSc, MeH, Universidad de Antioquia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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