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

National and Kapodistrian University of Athens

Status: Completed

Conditions: COVID-19 Infection

Treatments: Procedure: Convalescent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04408209

245-14-4-20

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Convalescent Plasma

Experimental group

Description:

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

Treatment:

Procedure: Convalescent Plasma