Study name |
Pilot study for use of convalescent plasma collected from patients recovered from COVID‐19 disease for transfusion as an empiric treatment during the 2020 pandemic at the University of Chicago Medical Center |
Methods |
|
Participants |
-
Inclusion criteria
≥ 18 years
Laboratory‐confirmed COVID‐19
Severe or immediately life‐threatening COVID‐19. (Severe defined as dyspnoea, respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, PaO2/FiO2 < 300, and/or lung infiltrates > 50% within 24‐ 48 h. Life‐threatening defined as respiratory failure, septic shock, and/or multiple organ dysfunction or failure. Lower priority should be given to patients with septic shock or multiple organ dysfunction or failure since their disease may have progressed to a point where they are not able to benefit from CP therapy)
Must be < 21 days from the start of illness
Written informed consent, willingness to comply with all protocol requirements, agreement to storage of specimens for future testing from patient or power of attorney or a healthcare proxy
-
Exclusion criteria
Positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
Receipt of pooled immunoglobulin in past 30 days
Contraindication to transfusion or history of prior reactions to transfusion blood products
Patients currently enrolled in other drug trials that preclude investigational treatment with anti‐SARS‐CoV‐2 CP
|
Interventions |
CP therapy or hyperimmune immunoglobulin therapy: CP therapy
-
Details of CP:
Treatment details, including time of plasma therapy (e.g. early stage of disease): must be < 21 days from the start of illness
For studies including a control group: comparator (type): not applicable
Concomitant therapy: NR
Treatment cross‐overs: not applicable
|
Outcomes |
Primary study outcome: feasibility of performing study pathway, type of respiratory support
-
Primary review outcomes
-
Secondary review outcomes
Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): NR
Number of participants with SAEs: NR
Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: yes
30‐day and 90‐day mortality: NR
Admission on the ICU: yes
Length of stay on the ICU: yes
Time to discharge from hospital: yes
QoL: NR
-
Additional outcomes
Feasibility of performing study pathway consisting of consenting convalescent donors, harvesting CP, application for FDA emergency investigational new drug use for administering CP to the patients
Type of respiratory support defined as room air, high‐flow oxygen, intubation
Cardiac arrest
Time to transfer to ICU
ICU mortality
|
Starting date |
10 April 2020 |
Contact information |
Maria Lucia Madariaga, MD; 773‐270‐2004; mlmadariaga@bsd.uchicago.edu |
Notes |
|