COVID-19
Conditions
Keywords
hyperimmune plasma, COVID-19
Brief summary
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become pandemic. To date, no specific treatment has been proven to be effective. Promising results were obtained in China using Hyperimmune plasma from patients recovered from the disease.The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.
Detailed description
Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately. Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.
Interventions
OTHERhyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
Sponsors
OSPEDALE CARLO POMA ASST MANTOVA
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>=18 yrs * positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2 * Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days * Polymerase chain reaction (PCR) increased by 3.5 with respect to baseline or \>1.8 mg/dl * need for mechanical ventilation or continuous positive airway pressure (CPAP) * signed informed consent unless unfeasible for the critical condition
Exclusion criteria
* Moderate to severe ARDS lasting more than 10 days * proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins * consent denied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death | within 7 days | death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to extubation | within 7 days | days since intubation |
| length of intensive care unit stay | within 7 days | days from entry to exit from ICU |
| time to CPAP weaning | within 7 days | days since CPAP initiation |
| viral load | at days 1, 3 and 7 | naso-pharyngeal swab, sputum and BAL |
| immune response | at days 1, 3 and 7 | neutralizing title |
Countries
Italy
Outcome results
None listed