Overview

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

Eligibility

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 0.5g/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