Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-07-02
2022-07-02
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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hyperimmune plasma
treated with hyperimmune plasma
treated with hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
Interventions
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treated with hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* consent denied
18 Years
ALL
Yes
Sponsors
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ANNA FALANGA
OTHER
Responsible Party
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ANNA FALANGA
Prof
Locations
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Anna Falanga
Bergamo, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IMMUNO-COVID19
Identifier Type: -
Identifier Source: org_study_id