Official Title
Convalescent Plasma for the Treatment of Patients With Severe COVID-19 Infection - A Multicenter Phase II Trial
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.

Covid-19 Infection

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

Eligibility 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

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A

"Evangelismos" General Hospital
Athens, Attiki, Greece

"Agios Savas" Oncology Hospital
Athens, Attiki, Greece

"Alexandra" General Hospital
Athens, Attiki, Greece

"Sotiria" General Hospital
Athens, Attiki, Greece

Attikon" University General Hospital
Athens, Chaidari, Greece

University General Hospital of Patras
Patra, Rio, Greece


Aikaterini Niarchou
+30 6949124743

Ioanna Charitaki
+30 6976156403

Hellenic Society of Hematology
NCT Number
MeSH Terms
Communicable Diseases