Covid19
Conditions
Keywords
covid19, Hospitalized patients, Hyperimmune plasma
Brief summary
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. 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 and womens , 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
OTHERtreated with hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
Sponsors
ANNA FALANGA
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
Yes
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) positive * signed informed consent unless unfeasible for the critical condition
Exclusion criteria
* proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins * consent denied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | within 30 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 |
| length of hospitalization | within 30 days | days from entry to exit from hospital |
| immune response | at days 1, 3 and 7 | neutralizing title |
| viral load | at days 1, 3 and 7 | naso-pharyngeal swab and BAL |
Countries
Italy
Contacts
Primary ContactAnna Falanga
Outcome results
None listed