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

Primary Purpose

Infections, Coronavirus

Status
Unknown status
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Inactivated convalescent plasma
Support treatment
Sponsored by
National Blood Center Foundation, Hemolife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Coronavirus focused on measuring CoViD-19, Pathogen inactivation, Apheresis, Convalescent plasma

Eligibility Criteria

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

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

Sites / Locations

  • Clínica Antioquía
  • Clínica Sagrado Corazón
  • IPS Universitaria
  • Universidad de Antioquía
  • National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
  • Clínica Rosales
  • Clinica Nuestra
  • Clínica Corpas
  • E.S.E Hospital San Rafael Facatativa
  • Clínica la Estancia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Convalescent plasma+Support treatment selected by the hospital

Support treatment selected by the hospital

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
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

Secondary Outcome Measures

Clinical evolution
Number of Participants with resolution of fever (<38ºC temperature)
Clinical evolution by seven-parameter ordinal scale
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
Multi-organ failure progression
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
Change in hemoglobin concentration
Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment
Change in blood cell count
Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment
Change in serum creatinine level
Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment
Change in aspartate aminotransferase level
Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment
Change in alanin aminotransferase level
Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment
Change in bilirubin level
Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment
Change in lactate dehydrogenase level
Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment
Change in creatine kinase level
Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment
Change in creatine kinase MB level
Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment
Change in C reactive protein concentration
Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L
Change in D Dimer concentration
Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment
Change in Procalcitonin concentration
Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment
Change in IL6 level
Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment
Radiography imaging
Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)
Tomography imaging
Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Assessment of oxygenation
Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio
Viral Load
Viral Load Quantification
Antibody titer
Neutralizing antibody anti SARS-CoV-2 titer evolution
Oxygen-free days through Day 60
Number of days without use of Oxygen
Mechanical ventilation-free days through Day 28
Number of days without use of mechanical ventilation
Intensive Care Unit (ICU)-free days through Day 28
Time outside of ICU, in days
Hospital-free days through Day 60
Time outside of the hospital, in days

Full Information

First Posted
May 6, 2020
Last Updated
May 30, 2020
Sponsor
National Blood Center Foundation, Hemolife
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1. Study Identification

Unique Protocol Identification Number
NCT04385186
Brief Title
Inactivated Convalescent Plasma as a Therapeutic Alternative in Patients CoViD-19
Official Title
Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2020 (Anticipated)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Blood Center Foundation, Hemolife

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Coronavirus
Keywords
CoViD-19, Pathogen inactivation, Apheresis, Convalescent plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
MULTICENTER, CONTROLLED, RANDOMIZED, SIMPLE BLIND, CLINICAL TRIAL
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Convalescent plasma+Support treatment selected by the hospital
Arm Type
Experimental
Arm Description
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.
Arm Title
Support treatment selected by the hospital
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Inactivated convalescent plasma
Other Intervention Name(s)
Inactivated convalescent plasma SARS-Cov-2 + Support treatment
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Support treatment
Other Intervention Name(s)
Support treatment under medical decision
Intervention Description
Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
Primary Outcome Measure Information:
Title
Mortality reduction in CoViD-19 patients treated with inactivated convalescent plasma + support treatment
Description
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
Time Frame
Over a period of 28 days
Secondary Outcome Measure Information:
Title
Clinical evolution
Description
Number of Participants with resolution of fever (<38ºC temperature)
Time Frame
Over a period of 28 days
Title
Clinical evolution by seven-parameter ordinal scale
Description
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
Time Frame
3, 7, 14 and 28 days
Title
Multi-organ failure progression
Description
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
Time Frame
3, 7, 14 and 28 days
Title
Change in hemoglobin concentration
Description
Compare the change in hemoglobin concentration at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in blood cell count
Description
Compare the change in blood cell count at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in serum creatinine level
Description
Compare the change in Serum creatinine concentration at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in aspartate aminotransferase level
Description
Compare the change in aspartate aminotransferase level at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in alanin aminotransferase level
Description
Compare the change in Alanine aminotransferase levels at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in bilirubin level
Description
Compare the change in bilirubin levels at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in lactate dehydrogenase level
Description
Compare the change in lactate dehydrogenase levels at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in creatine kinase level
Description
Compare the change in creatine kinase levels at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in creatine kinase MB level
Description
Compare the change in creatine kinase MB levels at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in C reactive protein concentration
Description
Compare the change in C reactive protein concentration at 3, 7, 14 and 28 days after treatment, in mg/L
Time Frame
3, 7, 14 and 28 days
Title
Change in D Dimer concentration
Description
Compare the change in D Dimer concentration at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in Procalcitonin concentration
Description
Compare the change in procalcitonin concentration at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Change in IL6 level
Description
Compare the change in IL6 level at 3, 7, 14 and 28 days after treatment
Time Frame
3, 7, 14 and 28 days
Title
Radiography imaging
Description
Resolution of chest radiography imaging findings (example, bilateral, peripheral and basal predominant ground-glass opacity, consolidation, or both)
Time Frame
Over a period of 60 days
Title
Tomography imaging
Description
Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)
Time Frame
Over a period of 60 days
Title
Assessment of oxygenation
Description
Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio
Time Frame
3, 7, 14 and 28 days
Title
Viral Load
Description
Viral Load Quantification
Time Frame
0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first
Title
Antibody titer
Description
Neutralizing antibody anti SARS-CoV-2 titer evolution
Time Frame
Day 0, Day 3 and Day 7
Title
Oxygen-free days through Day 60
Description
Number of days without use of Oxygen
Time Frame
Until hospital discharge or a maximum of 60 days whichever comes first
Title
Mechanical ventilation-free days through Day 28
Description
Number of days without use of mechanical ventilation
Time Frame
Until hospital discharge or a maximum of 28 days whichever comes first
Title
Intensive Care Unit (ICU)-free days through Day 28
Description
Time outside of ICU, in days
Time Frame
Until hospital discharge or a maximum of 28 days whichever comes first
Title
Hospital-free days through Day 60
Description
Time outside of the hospital, in days
Time Frame
Until hospital discharge or a maximum of 60 days whichever comes first
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events
Description
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
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrés F Zuluaga, MD, MSc, MeH
Phone
3014020291
Email
andres.zuluaga@udea.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Ana L Muñoz, MSc, PhD
Email
ana.munoz@hemolifeamerica.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés F Zuluaga, MD, MSc, MeH
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica Antioquía
City
Medellín
State/Province
Antioquía
ZIP/Postal Code
0500
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Gómez, MD. MSc
Email
diego.gomez@clinicanuestra.com
Facility Name
Clínica Sagrado Corazón
City
Medellín
State/Province
Antioquía
ZIP/Postal Code
0500
Country
Colombia
Facility Name
IPS Universitaria
City
Medellín
State/Province
Antioquía
ZIP/Postal Code
0500
Country
Colombia
Facility Name
Universidad de Antioquía
City
Medellín
State/Province
Antioquía
ZIP/Postal Code
0500
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés F Zuluaga, MD, MSc, MeH
Phone
3014020291
Email
andres.zuluaga@udea.edu.co
First Name & Middle Initial & Last Name & Degree
Amanda E Maestre, MD, PhD
Facility Name
National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
1101
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana L Muñoz, MSc, PhD
Phone
+573128879089
Email
ana.munoz@hemolifeamerica.org
First Name & Middle Initial & Last Name & Degree
Ana L Muñoz, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Miguel G Rueda, MD, MSc
First Name & Middle Initial & Last Name & Degree
Carlos A Arbelaez, MD, MSc
First Name & Middle Initial & Last Name & Degree
Fabian H Muñoz, MD, MSc
Facility Name
Clínica Rosales
City
Pereira
State/Province
Risaralda
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Gómez, MD, MSc
Email
diego.gomez@clinicanuestra.com
Facility Name
Clinica Nuestra
City
Cali
State/Province
Valle
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Gómez, MD, Msc
Email
diego.gomez@clinicanuestra.com
Facility Name
Clínica Corpas
City
Bogotá
Country
Colombia
Facility Name
E.S.E Hospital San Rafael Facatativa
City
Facatativa
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando J Charries, MD, MSc
First Name & Middle Initial & Last Name & Degree
José R Almarales, MD, MSc
Facility Name
Clínica la Estancia
City
Popayán
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Gómez, MD, MSc
Email
diego.gomez@clinicanuestra.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32319102
Citation
Epstein J, Burnouf T. Points to consider in the preparation and transfusion of COVID-19 convalescent plasma. Vox Sang. 2020 Aug;115(6):485-487. doi: 10.1111/vox.12939. Epub 2020 May 14. No abstract available.
Results Reference
background
PubMed Identifier
32219428
Citation
Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
Results Reference
background
PubMed Identifier
32167489
Citation
Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
Results Reference
background
Links:
URL
https://iris.paho.org/handle/10665.2/52036
Description
Regulatory considerations for the use of convalescent plasma to CoViD-19 emergency

Learn more about this trial

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

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