COVID-19 Convalescent Plasma TreatmentEPIC-19NCT04642014
Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Evaluation of Therapy Effectiveness
A study testing COVID-19 convalescent plasma treatment in people with COVID-19 Convalescent Plasma Treatment, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Convalescent Plasma Treatment
- What is being tested?
- COVID-19 convalescent plasma treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 sitePoland
- Study dates
- 22 Dec 2020to 4 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
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
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.
Read the 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.
- Conditions
- COVID-19 Convalescent Plasma Treatment
- Being tested
- COVID-19 convalescent plasma treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 convalescent plasma treatmentBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients with SARS CoV-2 infection | Experimental | Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma Receives: Biological: COVID-19 convalescent plasma treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, for any reason
Death, for any reason
Measured: 28 days after transfusion
Secondary outcomes (5)
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)
Measured: 28 days after transfusion
Stay in the intensive care unit (ICU)
Stay in the intensive care unit (ICU)
Measured: 28 days after transfusion
Time to disconnect CPAP respiratory support
Time to disconnect CPAP respiratory support
Measured: 28 days after transfusion
Time to elimination of SARS-Cov-2 (RT-PCR)
Time to elimination of SARS-Cov-2 (RT-PCR)
Measured: 28 days after transfusion
Time to serological response (anti-SARS-COv-2 antibodies)
Time to serological response (anti-SARS-COv-2 antibodies)
Measured: 3, 7, 28 days after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start22 Dec 2020
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Convalescent Plasma TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is going to recruit 300 convalescent plasma donors and 200 recipients
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642014
- Sponsor's protocol ID
- 2020.ABM.COVID19.0005
- Acronym
- EPIC-19
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32356910Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.
PubMed 32492084Duan 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.
PubMed 32253318Ye 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.
PubMed 32293713Yigenoglu 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.
PubMed 32643200Joyner 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.
PubMed 32525844
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04642014
- Acronym / sponsor ID
- EPIC-19 / 2020.ABM.COVID19.0005
- Conditions
- COVID-19 Convalescent Plasma Treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is going to recruit 300 convalescent plasma donors and 200 recipients
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients with SARS CoV-2 infection | Experimental | Biological: COVID-19 convalescent plasma treatmentHospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- No informed consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 convalescent plasma treatmentThe 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. | Biological | Hospitalized patients with SARS CoV-2 infection |
Primary outcome
Death, for any reason
Time frame: 28 days after transfusion
Death, for any reason
5 secondary outcomes
For patients with respiratory support, the time to take one's own breath (extubation)
Time frame: 28 days after transfusion
Stay in the intensive care unit (ICU)
Time frame: 28 days after transfusion
Time to disconnect CPAP respiratory support
Time frame: 28 days after transfusion
Time to elimination of SARS-Cov-2 (RT-PCR)
Time frame: 28 days after transfusion
Time to serological response (anti-SARS-COv-2 antibodies)
Time frame: 3, 7, 28 days after transfusion
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 32356910Rajendran 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.
- Background: PubMed 32492084Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, Hu C, Tao C, Yang R, Wang J, Yu Y, Guo Y, Wu X, Xu Z, Zeng L, Xiong N, Chen L, Wang J, Man N, Liu Y, Xu H, Deng E, Zhang X, Li C, Wang C, Su S, Zhang L, Wang J, Wu Y, Liu Z. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):460-470. doi: 10.1001/jama.2020.10044.
- Background: PubMed 32253318Duan 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.
- Background: PubMed 32293713Ye 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.
- Background: PubMed 32643200Yigenoglu 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.
- Background: PubMed 32525844Joyner 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.
- Individual participant dataSharing planned: Yes
Related trials for COVID-19 Convalescent Plasma Treatment
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
RecruitingPhase 2
Convalescent Plasma as a Possible Treatment for COVID-19
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 convalescent plasma treatment in people with COVID-19 Convalescent Plasma Treatment, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death, for any reason (time frame: 28 days after transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642014, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.