Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to 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 and will be available when sufficient numbers of people have recovered. Such persons should have high titer neutralizing immunoglobulin-containing plasma.
Subjects will receive open-label screened plasma from COVID-19+ clinically resolved individuals (≥14 days post-resolution). Dosing of single or double plasma units (weight based \< and \> 90Kg) will be administered on days 0, 2, 4, 6, and 8 (based on plasma availability), or until futility (if either occurs before day 8) is determined by the ICU. Doses can be omitted at the discretion of the treating clinician (e.g., TRALI events are 100% donor-dependent and do not prohibit future transfusions). The study drug is the investigational product, anti-SARS-CoV-2 convalescent plasma obtained from the American Red Cross or local plasma supply (medicDal center or city/region-wide shared blood bank) from patients identified as having recovered from COVID-19. Donors and samples will be screened for infections transmitted via transfusion (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T.cruzi, ZIKV) both through the use of the uniform donor questionnaire and FDA mandated blood donor screening tests. Plasma will be collected using apheresis technology or whole blood collection in accordance with standard FDA and blood bank protocols.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
To determine feasibility of convalescent plasma for treating patients in the ICU with COVID-19.
Ascension Providence Hospital, Novi Campus
Novi, Michigan, United States
Ascension Providence Hospital, Southfield Campus
Southfield, Michigan, United States
Ascension Macomb-Oakland Hospital, Warren Campus
Warren, Michigan, United States
Transfusion of patients in the ICU with convalescent plasma for COVID-19-induced respiratory failure.
Identification of patient population in ICU that are in acute respiratory failure due to COVID-19 and transfuse with convalescent plasma
Time frame: Track patient progress for 28 days post initial convalescent dose.
Ventilatory free days
Measure reduction in ventilator use and/or changes in mechanical ventilator parameters
Time frame: Track patient progress for 28 days post initial convalescent dose.
Patient mortality (including death from any cause)
Measure length of stay from the time of admission to the hospital and subsequent admission to the ICU. Document resolution of COVID-19 infection or alternatively patient death.
Time frame: Track patient progress for 28 days post initial convalescent dose.
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