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

Primary Purpose

COVID-19 Infection

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Convalescent Plasma
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "Evangelismos" General HospitalRecruiting
  • "Agios Savas" Oncology HospitalRecruiting
  • "Alexandra" General HospitalRecruiting
  • "Sotiria" General HospitalRecruiting
  • Attikon" University General HospitalRecruiting
  • University General Hospital of PatrasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Convalescent Plasma

Arm Description

Convalescent Plasma - early treatment of patients with severe COVID-19

Outcomes

Primary Outcome Measures

Survival
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.
Survival
The primary endpoint of this trial is the survival on day 35.
Survival
The primary endpoint of this trial is the survival on day 60.

Secondary Outcome Measures

Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease
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.

Full Information

First Posted
May 25, 2020
Last Updated
September 26, 2022
Sponsor
National and Kapodistrian University of Athens
Collaborators
Hellenic Society of Hematology
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1. Study Identification

Unique Protocol Identification Number
NCT04408209
Brief Title
Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection
Official Title
Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens
Collaborators
Hellenic Society of Hematology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Convalescent Plasma
Arm Type
Experimental
Arm Description
Convalescent Plasma - early treatment of patients with severe COVID-19
Intervention Type
Procedure
Intervention Name(s)
Convalescent Plasma
Intervention Description
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: the titer of IgG anti-SARS-CoV-2 antibodies (Pasteur Institute) the titer of neutralizing anti-SARS-CoV-2 antibodies (Pasteur Institute)
Primary Outcome Measure Information:
Title
Survival
Description
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.
Time Frame
Day 21
Title
Survival
Description
The primary endpoint of this trial is the survival on day 35.
Time Frame
Day 35
Title
Survival
Description
The primary endpoint of this trial is the survival on day 60.
Time Frame
Day 60
Secondary Outcome Measure Information:
Title
Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease
Description
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.
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years Confirmed SARS-CoV2 infection by PCR of the nasal/pharyngeal swab, sputum, BAL Onset of the disease symptoms no more than 12 days before the inclusion of the patients in the trial 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 Life threatening infection as determined by one of the following: Respiratory failure Septic Shock Multiple organ failure 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: Critical illness due to progressive COVID-19 with expected survival time <48 hours Intubated patients >72 hours Chronic Heart failure NYHA 3 and/or preexisting left ventricular ejection fraction 30% Cardiovascular failure requiring 0.5μg/Kg/min nor-adrenaline or equivalent or more than 2 types of vasopressor medication Liver Cirrhosis Child C Liver failure with bilirubin >5X ULN and increase of ALT/AST (at least one >10X ULN) Previous history of allergic reaction to blood or blood products transfusion Known IgA deficiency Pregnancy Breast feeding women Pulmonary edema
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aikaterini Niarchou
Phone
+30 6949124743
Email
aniarchou@med.uoa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Ioanna Charitaki
Phone
+30 6976156403
Email
j.charitaki@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meletios Athanasios Dimopoulos
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evangelos Terpos, MD
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Study Chair
Facility Information:
Facility Name
"Evangelismos" General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
"Agios Savas" Oncology Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 22
Country
Greece
Individual Site Status
Recruiting
Facility Name
"Alexandra" General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
"Sotiria" General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon" University General Hospital
City
Athens
State/Province
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Patras
City
Patra
State/Province
Rio
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33920489
Citation
Pappa V, Bouchla A, Terpos E, Thomopoulos TP, Rosati M, Stellas D, Antoniadou A, Mentis A, Papageorgiou SG, Politou M, Kotanidou A, Kalomenidis I, Poulakou G, Jahaj E, Korompoki E, Grigoropoulou S, Hu X, Bear J, Karaliota S, Burns R, Pagoni M, Trontzas I, Grouzi E, Labropoulou S, Stamoulis K, Bamias A, Tsiodras S, Felber BK, Pavlakis GN, Dimopoulos MA. A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis. Microorganisms. 2021 Apr 11;9(4):806. doi: 10.3390/microorganisms9040806.
Results Reference
derived

Learn more about this trial

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

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