This is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Information about patient recovery will be collected from participants' electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with convalescent plasma under a separate expanded access protocol, NCT04372368.
This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and
SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent
plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute
respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be
enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be
enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND
expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a
separate treatment trial. This observational protocol will co-enroll patients in parallel
with the expanded access protocol and expects to enroll approximately the same number of
patients but no treatment will be provided as part of this protocol. Additionally, the
investigators will use Compass data with identifiers to pull information on hospitalized
control COVID19+ patients from hospital admission date 4/20 to current for comparison.
This protocol is limited to data collection using the EMR to evaluate outcomes following
COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and
analyzed outside of the expanded access protocol for distribution of COVID19 convalescent
plasma. For this protocol, only de-identified, discarded samples may be obtained during
routine patient care. Thus, consent will only be obtained from patients/subjects for
participation in data abstraction/analysis from the electronic medical record.
Inclusion Criteria:
- Age 18 years or older
- Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19
SARS-CoV-2 RT-PCR testing.
- Patient treated with COVID19 convalescent plasma.
- Patient or surrogate designated decision maker is willing and able to provide written
informed consent.
Exclusion Criteria:
- Receipt of pooled immunoglobulin in past 30 days
- Contraindication to transfusion or history of prior reactions to transfusion blood
products
Children's Hospital Colorado
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
UCHealth Memorial Hospital North
Colorado Springs, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
John D Beckham, MD, Principal Investigator
University of Colorado, Denver