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Anti COVID-19 Convalescent Plasma Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345679
Recruitment Status : Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Semmelweis University
University of Pécs
Hungarian National Blood Service
Humán Bioplazma Kft - Kedrion
Information provided by (Responsible Party):
Orthosera Kft.

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.


Condition or disease Intervention/treatment Phase
COVID 19 Biological: anti-SARS-CoV-2 convalescent plasma Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti COVID-19 Convalescent Plasma Therapy
Estimated Study Start Date : April 14, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: Hospitalized patients with SARS CoV-2 infection Biological: anti-SARS-CoV-2 convalescent plasma
Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~200 mL over 4 hours




Primary Outcome Measures :
  1. Changing of viral load of SARS-CoV2 [ Time Frame: Day 1,3, 7, 12 ]
    Copies of COVID-19 per ml


Secondary Outcome Measures :
  1. Changes in immunglobulin G COVID-19 antibody titer [ Time Frame: 12 days ]
    Immunoglobulin G COVID-19 antibodies Immunglobulin G antibody titer

  2. Changes at the cytokine pattern [ Time Frame: 12 days ]
  3. Intensive Care Unit Admission [ Time Frame: Day 7,12,28 ]
    Proportion of patients with Intensive Care Unit Admission requirement

  4. Length of hospital stay [ Time Frame: Day 7, 12, 28 ]
    Days of Hospitalization

  5. Duration of mechanical ventilation [ Time Frame: Day 7, 12, 28 ]
    Days with mechanical ventilation

  6. Clinical Status [ Time Frame: Day 7, 12, 28 ]
    Clinical status assessed according to the World Health Organization guideline

  7. Mortality [ Time Frame: Day 7, 12, 28 ]
    Proportion of death patients at days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345679


Contacts
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Contact: Eszter Fodor, medical doctor +36306640494 eszter.fodor@orthosera.com
Contact: Zsombor Lacza, MD, PhD +36305249554 zsombor.lacza@orthosera.com

Sponsors and Collaborators
Orthosera Kft.
Semmelweis University
University of Pécs
Hungarian National Blood Service
Humán Bioplazma Kft - Kedrion
Investigators
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Principal Investigator: Veronika Müller, MD, PhD Semmelweis University
Additional Information:
Publications:

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Responsible Party: Orthosera Kft.
ClinicalTrials.gov Identifier: NCT04345679    
Other Study ID Numbers: AntiCOVID19ORT
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Orthosera Kft.:
COVID-19
convalescent plasma
serum therapy