COVID-19 Infection
Conditions
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.
Interventions
PROCEDUREConvalescent 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: 1. the titer of IgG anti-SARS-CoV-2 antibodies (Pasteur Institute) 2. the titer of neutralizing anti-SARS-CoV-2 antibodies (Pasteur Institute)
Sponsors
Hellenic Society of Hematology
National and Kapodistrian University of Athens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Day 21 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement ie percentage of patients not fulfilling the criteria for severe disease | Day 21 | 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. |
Countries
Greece
Outcome results
None listed