Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
There are currently no proven therapeutic options for coronavirus disease (COVID-19), the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Human convalescent plasma is an option for treatment of COVID-19. Experience from prior outbreaks with other coronaviruses, such as SARS-CoV-1, MERS and H1N1 shows that convalescent plasma can be effective. Convalescent plasma will be obtained by plasmapheresis or regular whole blood donation in subjects who recovered from COVID-19 and who are otherwise eligible for donation according to the Institutional protocol. Recipients will be COVID-19 patients requiring hospitalization. A blood-type matched transfusion of convalescent plasma will be infused and recipients will be followed up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
Institute for Transfusion Medicine of RNM
Skopje, North Macedonia
Duration of Oxygenation Support
The total number of days patients required respiratory support.
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Hospital Length of Stay (LOS)
Total number of days patients were admitted to the hospital after convalescent plasma transfusion.
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
ICU Admission
Total number of subjects to be admitted to the ICU after the convalescent plasma transfusion.
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of Participants With Oxygenation Free Days
Number of participants without oxygenation support after receiving convalescent plasma
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of Participants With Serious Adverse Events
Number of participants with serious adverse events during the study protocol
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Type of Respiratory Support
Type of supplemental oxygen support (e.g. nasal canula, high flow nasal canula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation)
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)
Number of Participants With Different Clinical Outcomes Including Death, Critical Illness and Recovery
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Number of participants with different clinical outcomes including death, critical illness, limitation of activities and recovery
Time frame: 28 days after transfusion or until hospital discharge (whichever comes first)