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

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ClinicalTrials.gov Identifier: NCT04385186
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
National Blood Center Foundation, Hemolife

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.

Condition or disease Intervention/treatment Phase
Infections, Coronavirus Drug: Inactivated convalescent plasma Drug: Support treatment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: MULTICENTER, CONTROLLED, RANDOMIZED, SIMPLE BLIND, CLINICAL TRIAL
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Inactivated Convalescent Plasma as a Therapeutic Alternative in Hospitalized Patients CoViD-19
Estimated Study Start Date : June 20, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: Support treatment under medical decision




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical evolution [ Time Frame: Over a period of 28 days ]
    Number of Participants with resolution of fever (<38ºC temperature)

  2. 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. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)

  18. Tomography imaging [ Time Frame: Over a period of 60 days ]
    Resolution of tomography imaging (example, patches located in the subpleural regions of the lung)

  19. Assessment of oxygenation [ Time Frame: 3, 7, 14 and 28 days ]
    Arterial oxygen partial pressure (PaO2) in mmHg / Inspired fraction of oxygen (FIO2) ratio

  20. Viral Load [ Time Frame: 0, 3, 7 days and until hospital discharge or a maximum of 60 days whichever comes first ]
    Viral Load Quantification

  21. Antibody titer [ Time Frame: Day 0, Day 3 and Day 7 ]
    Neutralizing antibody anti SARS-CoV-2 titer evolution

  22. 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

  23. 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

  24. 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

  25. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385186


Contacts
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Contact: Andrés F Zuluaga, MD, MSc, MeH 3014020291 andres.zuluaga@udea.edu.co
Contact: Ana L Muñoz, MSc, PhD ana.munoz@hemolifeamerica.org

Locations
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Colombia
Clínica Antioquía
Medellín, Antioquía, Colombia, 0500
Contact: Diego Gómez, MD. MSc       diego.gomez@clinicanuestra.com   
Clínica Sagrado Corazón
Medellín, Antioquía, Colombia, 0500
IPS Universitaria
Medellín, Antioquía, Colombia, 0500
Universidad de Antioquía
Medellín, Antioquía, Colombia, 0500
Contact: Andrés F Zuluaga, MD, MSc, MeH    3014020291    andres.zuluaga@udea.edu.co   
Sub-Investigator: Amanda E Maestre, MD, PhD         
National Blood Center Foundation, Hemolife/Fundación Banco Nacional de Sangre Hemolife
Bogotá, Cundinamarca, Colombia, 1101
Contact: Ana L Muñoz, MSc, PhD    +573128879089    ana.munoz@hemolifeamerica.org   
Principal Investigator: Ana L Muñoz, MSc, PhD         
Sub-Investigator: Miguel G Rueda, MD, MSc         
Sub-Investigator: Carlos A Arbelaez, MD, MSc         
Sub-Investigator: Fabian H Muñoz, MD, MSc         
Clínica Rosales
Pereira, Risaralda, Colombia
Contact: Diego Gómez, MD, MSc       diego.gomez@clinicanuestra.com   
Clinica Nuestra
Cali, Valle, Colombia
Contact: Diego Gómez, MD, Msc       diego.gomez@clinicanuestra.com   
Clínica Corpas
Bogotá, Colombia
E.S.E Hospital San Rafael Facatativa
Facatativa, Colombia
Contact: Fernando J Charries, MD, MSc         
Sub-Investigator: José R Almarales, MD, MSc         
Clínica la Estancia
Popayán, Colombia
Contact: Diego Gómez, MD, MSc       diego.gomez@clinicanuestra.com   
Sponsors and Collaborators
National Blood Center Foundation, Hemolife
Investigators
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Principal Investigator: Andrés F Zuluaga, MD, MSc, MeH Universidad de Antioquia
Additional Information:
Publications:
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Responsible Party: National Blood Center Foundation, Hemolife
ClinicalTrials.gov Identifier: NCT04385186    
Other Study ID Numbers: CT01
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Blood Center Foundation, Hemolife:
CoViD-19
Pathogen inactivation
Apheresis
Convalescent plasma
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases