Anti COVID-19 Convalescent Plasma Therapy
Primary Purpose
COVID 19
Status
Unknown status
Phase
Early Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
anti-SARS-CoV-2 convalescent plasma
Sponsored by
About this trial
This is an interventional treatment trial for COVID 19 focused on measuring COVID-19, convalescent plasma, serum therapy
Eligibility Criteria
Inclusion criteria for blood donors :
- age : >18 and <60 years
- body weight : >50 kg
- confirmed previous SARS CoV-2 infection
- 2 negative SARS CoV-2 test result
- written informed consent
- neutralizing antibody titer min. 1 : 120
Exclusion criteria for blood donors :
- age : <18 or >60 years
- female subjects who are pregnant
- HIV1,2 hepatitis B,C or syphilis infection
to minimize the transfusional side effects our aim is to include mostly male donors.
Inclusion criteria for patients/recipients :
- age : >18 years
- admitted to hospital due to SARS CoV-2 infection
- written informed consent
Exclusion criteria for patients/recipients :
- age : <18 years
- female subjects who are pregnant or breastfeeding
- patients with prior allergic reaction to transfusion
- patients who received in the past 30 days immunoglobulin therapy
Sites / Locations
- Semmelweis University's Department of PulmonologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hospitalized patients with SARS CoV-2 infection
Arm Description
Outcomes
Primary Outcome Measures
Changing of viral load of SARS-CoV2
Copies of COVID-19 per ml
Secondary Outcome Measures
Changes in immunglobulin G COVID-19 antibody titer
Immunoglobulin G COVID-19 antibodies Immunglobulin G antibody titer
Changes at the cytokine pattern
Intensive Care Unit Admission
Proportion of patients with Intensive Care Unit Admission requirement
Length of hospital stay
Days of Hospitalization
Duration of mechanical ventilation
Days with mechanical ventilation
Clinical Status
Clinical status assessed according to the World Health Organization guideline
Mortality
Proportion of death patients at days
Full Information
NCT ID
NCT04345679
First Posted
April 11, 2020
Last Updated
February 23, 2021
Sponsor
Orthosera Kft.
Collaborators
Semmelweis University, University of Pecs, Hungarian National Blood Service, Humán Bioplazma Kft - Kedrion
1. Study Identification
Unique Protocol Identification Number
NCT04345679
Brief Title
Anti COVID-19 Convalescent Plasma Therapy
Official Title
Anti COVID-19 Convalescent Plasma Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthosera Kft.
Collaborators
Semmelweis University, University of Pecs, Hungarian National Blood Service, Humán Bioplazma Kft - Kedrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Why is the research needed? The pandemic known as COVID-19 is now spreading across the world with currently (April 10, 2020) more than 1 115 530 active cases and 96 791 deaths. In most affected countries the current goal is to 'flatten the curve' of the epidemic since there is no health care system that is able to treat an extremely high volume of patients all at once. There is a need for immediately applicable treatments for the patients at highest risk, which gains time until targeted therapies become available. A key feature in the pathomechanism of the disease is that the virus elicits an immunological over-reaction in the human body termed 'cytokine storm'. In susceptible patients this hyper-inflammation itself is a significant burden and may even inhibit the body to generate antibodies against the virus in adequate quantities. Therefore, identifying the subset of patients with excess cytokine response and supplementing them with convalescent plasma from recovered donors may be a life-saving treatment option.
What is our study about? In light of recent promising data on plasma therapy in the treatment of COVID-19 and other viral epidemics, there is a need for better understanding the cytokine response to the virus in order to better characterize the target population for convalescent plasma therapy.
Our hypothesis is that convalescent plasma transfusion from healthy donors who recovered from SARS CoV-2 is able to reduce the cytokine storm in addition to replenish the patient's own antibodies in the acutely infected phase of the disease.
A plasmapheresis donation of 400ml will be performed in subjects who recovered from COVID-19 and who are otherwise eligible for plasma donation. The sample will be tested for anti-SARS CoV-2 neutralizing antibody titers and those that reach the level of 1:320 will be processed for transfusion at the Hungarian National Transfusion Service.
Recipients will be COVID-19 patients requiring hospitalization regardless of the severity of the disease or other co-morbidities. A blood-type matched transfusion of 200 ml convalescent plasma will be infused in a single sitting through an iv. infusion of 4 hours.
Recipients will be followed up at days 1, 3,7,12, 17, 28 for clinical symptoms, antibody levels and cytokine response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19
Keywords
COVID-19, convalescent plasma, serum therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hospitalized patients with SARS CoV-2 infection
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
anti-SARS-CoV-2 convalescent plasma
Intervention Description
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~200 mL over 4 hours
Primary Outcome Measure Information:
Title
Changing of viral load of SARS-CoV2
Description
Copies of COVID-19 per ml
Time Frame
Day 1,3, 7, 12
Secondary Outcome Measure Information:
Title
Changes in immunglobulin G COVID-19 antibody titer
Description
Immunoglobulin G COVID-19 antibodies Immunglobulin G antibody titer
Time Frame
12 days
Title
Changes at the cytokine pattern
Time Frame
12 days
Title
Intensive Care Unit Admission
Description
Proportion of patients with Intensive Care Unit Admission requirement
Time Frame
Day 7,12,28
Title
Length of hospital stay
Description
Days of Hospitalization
Time Frame
Day 7, 12, 28
Title
Duration of mechanical ventilation
Description
Days with mechanical ventilation
Time Frame
Day 7, 12, 28
Title
Clinical Status
Description
Clinical status assessed according to the World Health Organization guideline
Time Frame
Day 7, 12, 28
Title
Mortality
Description
Proportion of death patients at days
Time Frame
Day 7, 12, 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for blood donors :
age : >18 and <60 years
body weight : >50 kg
confirmed previous SARS CoV-2 infection
2 negative SARS CoV-2 test result
written informed consent
neutralizing antibody titer min. 1 : 120
Exclusion criteria for blood donors :
age : <18 or >60 years
female subjects who are pregnant
HIV1,2 hepatitis B,C or syphilis infection
to minimize the transfusional side effects our aim is to include mostly male donors.
Inclusion criteria for patients/recipients :
age : >18 years
admitted to hospital due to SARS CoV-2 infection
written informed consent
Exclusion criteria for patients/recipients :
age : <18 years
female subjects who are pregnant or breastfeeding
patients with prior allergic reaction to transfusion
patients who received in the past 30 days immunoglobulin therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eszter Fodor, medical doctor
Phone
+36306640494
Email
eszter.fodor@orthosera.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zsombor Lacza, MD, PhD
Phone
+36305249554
Email
zsombor.lacza@orthosera.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronika Müller, MD, PhD
Organizational Affiliation
Semmelweis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University's Department of Pulmonology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronika Müller, MD
Phone
+3613559733
First Name & Middle Initial & Last Name & Degree
Veronika Müller, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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32219428
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Results Reference
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Links:
URL
http://apps.who.int/iris/bitstream/handle/10665/161912/WHO_HIS_KER_GHE_15.1_eng.pdf;jsessionid=F7C13F58F53ADE7D203B12781D96CF02?sequence=1
Description
12. Ethics of using convalescent whole blood and convalescent plasma during the Ebola epidemic. Interim guidance for ethics review committees, researchers, national health authorities and blood transfusion services. 2015 WHO/HIS/KER/GHE/15.1
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Anti COVID-19 Convalescent Plasma Therapy
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