Status:
COMPLETED
Hyperimmune Plasma for Critical Patients With COVID-19
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
OSPEDALE CARLO POMA ASST MANTOVA
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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 Ch...
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 d...
Eligibility Criteria
Inclusion
- 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
- Moderate to severe ARDS lasting more than 10 days
- proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
- consent denied
Key Trial Info
Start Date :
March 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04321421
Start Date
March 17 2020
End Date
May 7 2020
Last Update
May 28 2020
Active Locations (2)
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1
Catherine Klersy
Pavia, PV, Italy, 27100
2
Ospedale Asst Carlo Poma Mantova
Mantova, Italy, 46100