Clinical trials are being conducted to evaluate the use of COVID-19 convalescent plasma to treat patients with severe or immediately life-threatening COVID-19 infections.
COVID-19 convalescent plasma is not intended for prevention of the infection.
- To participate in these trials, investigators should submit requests to the FDA for investigational use under the traditional IND regulatory pathway.
- In addition to clinical trials, licensed physicians may obtain COVID-19 convalescent plasma for an individual patient through the process of single patient eINDs.
In a case series of 5 critically ill patients with confirmed COVID-19 and acute respiratory distress syndrome (ARDS), patients received convalescent plasma.
Treatment: 2 consecutive transfusions of 200 mL to 250 mL of convalescent plasma (total dose: 400 mL) with a SARS-CoV-2-specific antibody (IgG) titer greater than 1:1,000 on the same day it was obtained from the donor.
Patient criteria included:
- Severe pneumonia with rapid progression and continuously high viral load despite antiviral treatment
- PAO2/FIO2 less than 300
- Mechanical ventilation
After plasma infusion, body temperature normalized within 3 days in 4 of 5 patients, Sequential Organ Failure Assess (SOFA) score decreased and PAO2/FIO2 increased within 12 days.
Viral loads decreased and became negative within 12 days after the transfusion with the SARS-CoV-2-specific ELISA and neutralizing antibody titers increased after the transfusion.
ARDS resolved in 4 patients by day 12 after the transfusion and 3 patients were weaned from mechanical ventilation within 2 weeks of treatment.
Правительство Москвы. Департамент Здравоохранения города Москвы. Приказ от 01.04.2020 №325. О внедрении технологии использования свежезамороженной плазмы от доноров-реконвалесцентов COVID-19.
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