This is a Phase II study. This research study is being conducted to use convalescent donor plasma in seriously ill patients who have COVID-19.
This is an open label phase 2 trial assessing the efficacy and safety of anti-SARS-CoV-2
convalescent plasma in hospitalized patients with acute severe respiratory symptoms from
COVID-19. Symptomatic patients with clinical or radiological interstitial COVID-19 pneumonia
and within 21 days of onset of symptoms will be enrolled in 2 cohorts - an ICU cohort and a
hospitalized non-ICU cohort.
Biological: anti-SARS-CoV-2 convalescent plasma
SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL maximum dose as 7 ml/kg adjusted IBW )
Study drug will be administered as a single intravenous infusion
Inclusion Criteria:
1. Age ≥ 18 years or older
2. Hospitalized as an in-patient with positive COVID-19 test by PCR
3. Presence of respiratory symptoms with any of severe features as below:
- Respiratory Rate ≥ 24/min
- Oxygen Support >3L/min by nasal cannula
- New onset or worsening of respiratory symptoms with radiologic confirmation of
bilateral ground glass opacities that cannot be attributed to another cause
4. Patient / HCPOA must agree to storage of blood specimens for future testing.
5. Patient / HCPOA is willing and able to provide electronic informed consent and comply
with all protocol requirements. If patient is unable to consent due to incapacity,
health care POA should be defined and able to consent for the patient.
6. Patients are allowed to receive all standard of care. Co enrollment in other clinical
trials is permitted.
Exclusion Criteria:
1. FCBP with positive pregnancy test (mandatory)
2. Breastfeeding females
3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in
past 14 days. This does not apply to monoclonal antibodies .
4. Mechanical ventilation for > 14 days
5. Days from symptom onset >21 days
6. Expected survival < 72 hours
7. Contraindication to transfusion or history of prior reactions to transfusion blood
products including any proven history of TRALI
8. Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort.
These patients could need ICU level care subsequently and at that time point could be
considered for ICU cohort .
Froedtert Hospital
Milwaukee, Wisconsin, United States
Mary Beth Graham, Principal Investigator
Medical College of Wisconsin