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.
Drug: SARS-CoV-2 plasma
To determine feasibility of convalescent plasma for treating patients in the ICU with COVID-19.
Other Name: Convalescent plasma
Inclusion Criteria:
- Laboratory confirmed COVID-19
- Severe or Immediately life threatening COVID-19
- Dyspnea
- Respiratory frequency > 30/minute
- Blood oxygen saturation <93%
- Life-threatening disease is defined as the following
- Respiratory Failure.
- Septic shock, and/or,
- Multiple organ dysfunction or failure.
Exclusion Criteria:
- Contraindication to transfusion (severe volume overload, history of anaphylaxis to
blood products).
- Other documented uncontrolled infection.
- Severe DIC needing factor replacement, FFP, cryoprecipitate.
- On dialysis.
- Active intracranial bleeding.
- Clinically significant myocardial ischemia.
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