Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Evaluation of Therapy Effectiveness (EPIC-19)
Primary Purpose
COVID-19 Convalescent Plasma Treatment
Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
COVID-19 convalescent plasma treatment
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Convalescent Plasma Treatment
Eligibility Criteria
Inclusion Criteria:
Donors:
- Age >18 and <65 years
- Confirmed previous SARS CoV-2 infection
- Signed informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
- At least 28 days from the end of isolation or resolution of symptoms of infection
- Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
- Individuals who meet all regular voluntary donor eligibility requirements
Recipiants:
- Signed informed consent to participate in this clinical trial.
- Confirmed previous SARS CoV-2 infection
- Respiratory distress with tachypnoe ≥30 breaths per minute,
- Oxygen level less than 94% in resting-state,
- Partial pressure of oxygen (PO2) ≤ 80 mmHg
Exclusion Criteria:
Donors:
- Age : <18 or >65 years
- Female subjects who are pregnant
- HIV1,2 hepatitis B,C or syphilis infection
- Donors ineligible for regular voluntary blood donation
Recipiants:
- No informed consent to participate in the study
- Patients with a history of plasma hypersensitivity, including anaphylactic shock in previous transfusions, allergic reactions to citrate or primary IgA deficiency
- Patients with symptoms of severe multi-organ failure
- Patients with known allergic reactions to chemical compounds used or generated in the procedure of inactivation of pathogens
- Patients with active thrombosis
Sites / Locations
- Wroclaw Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hospitalized patients with SARS CoV-2 infection
Arm Description
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
Outcomes
Primary Outcome Measures
Death, for any reason
Death, for any reason
Secondary Outcome Measures
For patients with respiratory support, the time to take one's own breath (extubation)
For patients with respiratory support, the time to take one's own breath (extubation)
Stay in the intensive care unit (ICU)
Stay in the intensive care unit (ICU)
Time to disconnect CPAP respiratory support
Time to disconnect CPAP respiratory support
Time to elimination of SARS-Cov-2 (RT-PCR)
Time to elimination of SARS-Cov-2 (RT-PCR)
Time to serological response (anti-SARS-COv-2 antibodies)
Time to serological response (anti-SARS-COv-2 antibodies)
Full Information
NCT ID
NCT04642014
First Posted
November 23, 2020
Last Updated
March 24, 2022
Sponsor
Wroclaw Medical University
Collaborators
Medical Research Agency, Poland
1. Study Identification
Unique Protocol Identification Number
NCT04642014
Brief Title
Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Evaluation of Therapy Effectiveness
Acronym
EPIC-19
Official Title
A Multi-centre, 18-months, Single-group Study of Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Metabolomic and Laboratory Evaluation of Plasma Therapy Effectiveness
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The main reasons for the premature termination of the study are the inability to reliably assess the effectiveness of therapy due to the emergence of new variants of SARS-CoV-2 and reports of the lack of benefits of using plasma in previous studies.
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
January 4, 2022 (Actual)
Study Completion Date
January 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wroclaw Medical University
Collaborators
Medical Research Agency, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A Multi-centre, 18-months, Single-group Study of Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Metabolomic and Laboratory Evaluation of Plasma Therapy Effectiveness.
Detailed Description
The trial is designed as multi-centre, non-randomized, single-group with a primary endpoint of death of convalescent plasma recipient in twenty eight days. We are planning to recruit 300 donor patients who recovered from COVID-19 and who offer to take part in an experiment based on the informed consent form. The recovery criteria involve body temperature normalization for more than 3 days, resolution of respiratory tract symptoms, and two consecutively negative results of SARS-CoV-2 RT-PCR assay test. The donor's blood will be collected after four weeks post-onset of illness. 600 ml ABO-compatible plasma sample will be harvested during apheresis from each donor and each sample will be divided and stored as 200 mL aliquots. The plasma recipients are adult patients diagnosed with COVID-19 according to the WHO Interim Guidance with confirmation by real-time RT-PCR assay The inclusion criteria to receive plasma assume to meet at least one of following : respiratory distress with tachypnoe ≥30 breaths per minute, oxygen level less than 94% in resting-state, partial pressure of oxygen (PO2) ≤ 80 mmHg. Patients who meet the criteria receive one dose (200 mL) of ABO compatible inactivated convalescent plasma with a confirmed neutralization activity. The recipient are going to undergo detailed clinical evaluation along with the assessment of biochemical parameters, complete blood count and inflammation indicators. The study involves a comprehensive assessment of the serological response of patients with different course of SARS-Cov-2 infection, as well as an analysis of the impact of the level of antibodies in the donor's plasma on the clinical response in patients with COVID-19. In addition, a comprehensive metabolomic analysis of donor and recipient blood was planned to identify prognostic and predictive factors. The endpoints include the safety of convalescents plasma transfusion, as well as the improvement of clinical symptoms and laboratory parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Convalescent Plasma Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is going to recruit 300 convalescent plasma donors and 200 recipients
Masking
None (Open Label)
Allocation
N/A
Enrollment
396 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hospitalized patients with SARS CoV-2 infection
Arm Type
Experimental
Arm Description
Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma
Intervention Type
Biological
Intervention Name(s)
COVID-19 convalescent plasma treatment
Intervention Description
The donor's blood will be collected after four weeks post-onset of illness. 600 ml ABO-compatible plasma sample will be harvested during apheresis from each donor and each sample will be divided and stored as 200 mL aliquots.
Patients who meet the criteria receive one dose (200 mL) of ABO compatible inactivated convalescent plasma with a confirmed neutralization activity.
Primary Outcome Measure Information:
Title
Death, for any reason
Description
Death, for any reason
Time Frame
28 days after transfusion
Secondary Outcome Measure Information:
Title
For patients with respiratory support, the time to take one's own breath (extubation)
Description
For patients with respiratory support, the time to take one's own breath (extubation)
Time Frame
28 days after transfusion
Title
Stay in the intensive care unit (ICU)
Description
Stay in the intensive care unit (ICU)
Time Frame
28 days after transfusion
Title
Time to disconnect CPAP respiratory support
Description
Time to disconnect CPAP respiratory support
Time Frame
28 days after transfusion
Title
Time to elimination of SARS-Cov-2 (RT-PCR)
Description
Time to elimination of SARS-Cov-2 (RT-PCR)
Time Frame
28 days after transfusion
Title
Time to serological response (anti-SARS-COv-2 antibodies)
Description
Time to serological response (anti-SARS-COv-2 antibodies)
Time Frame
3, 7, 28 days after transfusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Donors:
Age >18 and <65 years
Confirmed previous SARS CoV-2 infection
Signed informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.
At least 28 days from the end of isolation or resolution of symptoms of infection
Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies
Individuals who meet all regular voluntary donor eligibility requirements
Recipiants:
Signed informed consent to participate in this clinical trial.
Confirmed previous SARS CoV-2 infection
Respiratory distress with tachypnoe ≥30 breaths per minute,
Oxygen level less than 94% in resting-state,
Partial pressure of oxygen (PO2) ≤ 80 mmHg
Exclusion Criteria:
Donors:
Age : <18 or >65 years
Female subjects who are pregnant
HIV1,2 hepatitis B,C or syphilis infection
Donors ineligible for regular voluntary blood donation
Recipiants:
No informed consent to participate in the study
Patients with a history of plasma hypersensitivity, including anaphylactic shock in previous transfusions, allergic reactions to citrate or primary IgA deficiency
Patients with symptoms of severe multi-organ failure
Patients with known allergic reactions to chemical compounds used or generated in the procedure of inactivation of pathogens
Patients with active thrombosis
Facility Information:
Facility Name
Wroclaw Medical University
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
50-556
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
32356910
Citation
Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.
Results Reference
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32492084
Citation
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Results Reference
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PubMed Identifier
32253318
Citation
Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
Results Reference
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PubMed Identifier
32293713
Citation
Ye M, Fu D, Ren Y, Wang F, Wang D, Zhang F, Xia X, Lv T. Treatment with convalescent plasma for COVID-19 patients in Wuhan, China. J Med Virol. 2020 Oct;92(10):1890-1901. doi: 10.1002/jmv.25882. Epub 2020 Jun 29.
Results Reference
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PubMed Identifier
32643200
Citation
Yigenoglu TN, Hacibekiroglu T, Berber I, Dal MS, Basturk A, Namdaroglu S, Korkmaz S, Ulas T, Dal T, Erkurt MA, Turgut B, Altuntas F. Convalescent plasma therapy in patients with COVID-19. J Clin Apher. 2020 Aug;35(4):367-373. doi: 10.1002/jca.21806. Epub 2020 Jul 9.
Results Reference
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PubMed Identifier
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Citation
Joyner MJ, Wright RS, Fairweather D, Senefeld JW, Bruno KA, Klassen SA, Carter RE, Klompas AM, Wiggins CC, Shepherd JR, Rea RF, Whelan ER, Clayburn AJ, Spiegel MR, Johnson PW, Lesser ER, Baker SE, Larson KF, Ripoll JG, Andersen KJ, Hodge DO, Kunze KL, Buras MR, Vogt MN, Herasevich V, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, Van Buskirk CM, Winters JL, Stubbs JR, Paneth NS, Verdun NC, Marks P, Casadevall A. Early safety indicators of COVID-19 convalescent plasma in 5000 patients. J Clin Invest. 2020 Sep 1;130(9):4791-4797. doi: 10.1172/JCI140200.
Results Reference
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Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Evaluation of Therapy Effectiveness
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