Status:
COMPLETED
Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
Hellenic Society of Hematology
Conditions:
COVID-19 Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04408209
Start Date
April 23 2020
End Date
December 15 2023
Last Update
November 18 2024
Active Locations (6)
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1
"Evangelismos" General Hospital
Athens, Attica, Greece, 10676
2
"Agios Savas" Oncology Hospital
Athens, Attica, Greece, 115 22
3
"Alexandra" General Hospital
Athens, Attica, Greece, 115 28
4
"Sotiria" General Hospital
Athens, Attica, Greece, 11527