This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.
This is an expanded access treatment protocol to treat up to 100 subjects with severe or
life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects
will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible,
low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one
unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours
(rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be
administered following standard institutional procedures, including the use of premedications
(e.g. acetaminophen, diphenhydramine, etc.) as necessary.
Biological: Convalescent Plasma
1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma
Inclusion Criteria:
- Male or Female
- 18 years of age or older
- Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing
- Patients currently hospitalized with severe or life-threatening COVID-19 or patients
the treating physician deems to be at high-risk for progressing to severe or
life-threatening COVID-19.
- Severe disease, defined as one or more of the following:
- dyspnea,
- respiratory frequency ≥ 30/min,
- blood oxygen saturation ≤ 93%,
- partial pressure of arterial oxygen to fraction of inspired oxygen ratio <
300, and/or
- lung infiltrates > 50% within 24 to 48 hours
- Life-threatening disease, defined as one or more of the following:
- respiratory failure,
- septic shock, and/or
- multiple organ dysfunction or failure
- Patients or their legally authorized representative must provide informed consent.
Exclusion Criteria:
- Female patients with positive pregnancy test, breastfeeding, or planning to become
pregnant/breastfeed during the study period.
- Patients who have received pooled immunoglobulin in past 30 days
- Contraindication to transfusions or history of prior reactions to transfusion blood
products