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

March 24, 2022 updated by: Wroclaw Medical University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

396

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 50-556
        • Wroclaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death, for any reason
Time Frame: 28 days after transfusion
Death, for any reason
28 days after transfusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For patients with respiratory support, the time to take one's own breath (extubation)
Time Frame: 28 days after transfusion
For patients with respiratory support, the time to take one's own breath (extubation)
28 days after transfusion
Stay in the intensive care unit (ICU)
Time Frame: 28 days after transfusion
Stay in the intensive care unit (ICU)
28 days after transfusion
Time to disconnect CPAP respiratory support
Time Frame: 28 days after transfusion
Time to disconnect CPAP respiratory support
28 days after transfusion
Time to elimination of SARS-Cov-2 (RT-PCR)
Time Frame: 28 days after transfusion
Time to elimination of SARS-Cov-2 (RT-PCR)
28 days after transfusion
Time to serological response (anti-SARS-COv-2 antibodies)
Time Frame: 3, 7, 28 days after transfusion
Time to serological response (anti-SARS-COv-2 antibodies)
3, 7, 28 days after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Collaborators

Medical Research Agency, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 22, 2020

Primary Completion (ACTUAL)

January 4, 2022

Study Completion (ACTUAL)

January 4, 2022

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (ACTUAL)

November 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.ABM.COVID19.0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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