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Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection

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: NCT04408209
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
Hellenic Society of Hematology
Information provided by (Responsible Party):
Professor Meletios-Athanasios Dimopoulos, National and Kapodistrian University of Athens

Brief Summary:
This is a multicenter, Phase 2 study, to assess the efficacy of the treatment with convalescent plasma in patients with severe COVID-19 infection.

Condition or disease Intervention/treatment Phase
COVID-19 Infection Procedure: Convalescent Plasma Not Applicable

Detailed Description:
Convalescent plasma will be collected by plasmapheresis from patients fully recovered from COVID-19 infection and will be administered in patients with severe COVID-19 infection. The results will be compared with an historical matched control.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : September 15, 2021

Arm Intervention/treatment
Experimental: Convalescent Plasma
Convalescent Plasma - early treatment of patients with severe COVID-19
Procedure: Convalescent Plasma

Convalescent Plasma - early treatment of patients with severe COVID-19. Clinical and laboratory data of patients will be collected before initiation of the procedure, 30 minutes after the first dose, 30 minutes after the second dose and 30 minutes after the third plasma dose and then on days 1-7, 14, 21, 28, 35 from the start of treatment. In case of adverse reactions during transfusion such as acute shortness of breath, haemodynamic instability or high pre-existing and non-disease-related fever, the transfusion will be interrupted and detailed recording of the event as well as updating the Adverse Events Management Committee will be performed.

In addition to the standard assessments, the titer of neutralizing anti-SARS-CoV-2 antibodies will be measured in a sample drawn prior to plasmapheresis.

All donors will be tested for:

  1. the titer of IgG anti-SARS-CoV-2 antibodies (Pasteur Institute)
  2. the titer of neutralizing anti-SARS-CoV-2 antibodies (Pasteur Institute)




Primary Outcome Measures :
  1. Survival [ Time Frame: Day 21 ]
    The primary endpoint of this trial is the survival on day 21. The primary endpoint, as a dichotomous composite of survival (yes/no) and no longer fulfilling criteria of severe COVID-19, will be analyzed according their classification. Specifically, categorical variables will be analyzed by means of absolute and relative frequencies, and all continuous variables will be described using arithmetic mean, standard deviation, median, quartiles. Also, geometric means, variance and 95% confidence intervals (CI), will be calculated for all pharmacokinetics parameters.

  2. Survival [ Time Frame: Day 35 ]
    The primary endpoint of this trial is the survival on day 35.

  3. Survival [ Time Frame: Day 60 ]
    The primary endpoint of this trial is the survival on day 60.


Secondary Outcome Measures :
  1. Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease [ Time Frame: Day 21 ]
    The secondary endpoint of this trial is that no longer fulfilling criteria of severe COVID-19 within 21 days after inclusion. This will be assessed on the basis of respiratory rate and ventilation support.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Confirmed SARS-CoV2 infection by PCR of the nasal/pharyngeal swab, sputum, BAL
  3. Onset of the disease symptoms no more than 12 days before the inclusion of the patients in the trial
  4. Severe COVID-19 infection as determined with one of the following:

    • Respiratory rate 30/min
    • Oxygen Hemoglobin Saturation SAT 93
    • CRP >1.5 (upper normal limit <0.5)
    • Ferritin value >100
    • Ratio of PaO2:FiO2 <300mmHg
    • Pulmonary infiltrates in Chest X-Ray or Chest CT scan >50% during 24-48 hours
  5. Life threatening infection as determined by one of the following:

    • Respiratory failure
    • Septic Shock
    • Multiple organ failure
  6. Signature of informed consent by the patient or legal representative Patients fulfilling criteria 1, 2, 3, 6 and one of criteria 4 or 5 will be eligible for the study.

Exclusion Criteria:

  1. Critical illness due to progressive COVID-19 with expected survival time <48 hours
  2. Intubated patients >72 hours
  3. Chronic Heart failure NYHA 3 and/or preexisting left ventricular ejection fraction 30%
  4. Cardiovascular failure requiring 0.5μg/Kg/min nor-adrenaline or equivalent or more than 2 types of vasopressor medication
  5. Liver Cirrhosis Child C
  6. Liver failure with bilirubin >5X ULN and increase of ALT/AST (at least one >10X ULN)
  7. Previous history of allergic reaction to blood or blood products transfusion
  8. Known IgA deficiency
  9. Pregnancy
  10. Breast feeding women
  11. Pulmonary edema

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): NCT04408209


Contacts
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Contact: Aikaterini Niarchou +30 6949124743 aniarchou@med.uoa.gr
Contact: Ioanna Charitaki +30 6976156403 j.charitaki@gmail.com

Locations
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Greece
"Evangelismos" General Hospital Recruiting
Athens, Attiki, Greece, 10676
"Agios Savas" Oncology Hospital Recruiting
Athens, Attiki, Greece, 115 22
"Alexandra" General Hospital Recruiting
Athens, Attiki, Greece, 115 28
"Sotiria" General Hospital Recruiting
Athens, Attiki, Greece, 11527
Attikon" University General Hospital Recruiting
Athens, Chaidari, Greece, 124 62
University General Hospital of Patras Recruiting
Patra, Rio, Greece, 26504
Sponsors and Collaborators
National and Kapodistrian University of Athens
Hellenic Society of Hematology
Investigators
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Principal Investigator: Meletios Athanasios Dimopoulos National and Kapodistrian University of Athens
Study Chair: Evangelos Terpos, MD National and Kapodistrian University of Athens
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Responsible Party: Professor Meletios-Athanasios Dimopoulos, Professor & Rector of the NKU Athens Plasma Cell Dyscrasias Unit Section of Hematology & Medical Oncology Department of Clinical Therapeutics School of Medicine NKU Athens Alexandra Hospital, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT04408209    
Other Study ID Numbers: 245-14-4-20
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases