The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.
The purpose of this research study is to see if convalescent plasma is safe and effective for the treatment of patients acutely ill with COVID-19. The researchers want to confirm the right dose levels of immunoglobulins/antibodies (immune proteins) and find out what therapeutic effects plasma donated by recovered individuals has on people severely sick with COVID-19.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Change is Clinical Status
Change is clinical status as captured by 7-point ordinal scale to include 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized
Time frame: Time of plasma infusion (day 0) compared to day 7
Transfusion Related Events Due to Administration of CCP
Number of participants with Transfusion Related Adverse Events
Time frame: Within 6 hours of infusion
Change is Clinical Status
Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28. 7 point ordinal scale: 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized
Time frame: Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28
Length of Hospital Stay
Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)
Time frame: Total Index Hospitalization
Mechanical Ventilation
Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Days 7, 14, 21, 28
Change in Mechanical Ventilation Status
Number of participants who required a change in the mechanical ventilation status
Time frame: Day 0 (date of CCP transfusion) to Day 28
Mortality
All-cause Mortality
Time frame: From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.