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EPIC-19: Application of Convalescent Plasma in the Treatment of SARS CoV-2 Disease (COVID-19) With Evaluation of Therapy Effectiveness

Sponsor
Wroclaw Medical University (Other)
Overall Status
Terminated
CT.gov ID
NCT04642014
Collaborator
Medical Research Agency, Poland (Other)
396
Enrollment
1
Location
1
Arm
12.4
Actual Duration (Months)
31.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 convalescent plasma treatment
 N/A

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

Study Type:
Interventional
Actual Enrollment :
396 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study is going to recruit 300 convalescent plasma donors and 200 recipientsThe study is going to recruit 300 convalescent plasma donors and 200 recipients
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 22, 2020
Actual Primary Completion Date :
Jan 4, 2022
Actual Study Completion Date :
Jan 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hospitalized patients with SARS CoV-2 infection

Hospitalized patients with SARS CoV-2 infection will receive an anti SARS-CoV-2 convalescent plasma

Biological: COVID-19 convalescent plasma treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Death, for any reason [28 days after transfusion]

    Death, for any reason

Secondary Outcome Measures

  1. For patients with respiratory support, the time to take one's own breath (extubation) [28 days after transfusion]

    For patients with respiratory support, the time to take one's own breath (extubation)

  2. Stay in the intensive care unit (ICU) [28 days after transfusion]

    Stay in the intensive care unit (ICU)

  3. Time to disconnect CPAP respiratory support [28 days after transfusion]

    Time to disconnect CPAP respiratory support

  4. Time to elimination of SARS-Cov-2 (RT-PCR) [28 days after transfusion]

    Time to elimination of SARS-Cov-2 (RT-PCR)

  5. Time to serological response (anti-SARS-COv-2 antibodies) [3, 7, 28 days after transfusion]

    Time to serological response (anti-SARS-COv-2 antibodies)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Donors:

  1. Age >18 and <65 years

  2. Confirmed previous SARS CoV-2 infection

  3. Signed informed consent to participate in this clinical trial, to donate plasma and to store the specimen for future testing.

  4. At least 28 days from the end of isolation or resolution of symptoms of infection

  5. Male donors, or female donors who have not been pregnant, or female donors who have been pregnant tested negative for HLA antibodies

  6. Individuals who meet all regular voluntary donor eligibility requirements

Recipiants:

  1. Signed informed consent to participate in this clinical trial.

  2. Confirmed previous SARS CoV-2 infection

  3. Respiratory distress with tachypnoe ≥30 breaths per minute,

  4. Oxygen level less than 94% in resting-state,

  5. Partial pressure of oxygen (PO2) ≤ 80 mmHg

Exclusion Criteria:
Donors:

  1. Age : <18 or >65 years

  2. Female subjects who are pregnant

  3. HIV1,2 hepatitis B,C or syphilis infection

  4. Donors ineligible for regular voluntary blood donation

Recipiants:

  1. No informed consent to participate in the study

  2. Patients with a history of plasma hypersensitivity, including anaphylactic shock in previous transfusions, allergic reactions to citrate or primary IgA deficiency

  3. Patients with symptoms of severe multi-organ failure

  4. Patients with known allergic reactions to chemical compounds used or generated in the procedure of inactivation of pathogens

  5. Patients with active thrombosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wroclaw Medical University Wroclaw Dolnośląskie Poland 50-556

Sponsors and Collaborators

  • Wroclaw Medical University
  • Medical Research Agency, Poland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wroclaw Medical University
ClinicalTrials.gov Identifier:
NCT04642014
Other Study ID Numbers:
  • 2020.ABM.COVID19.0005
First Posted:
Nov 24, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Apr 5, 2022