The purpose of this study is to see if this plasma can be safely used in humans with COVID-19 and to see if it can improve patients' health when they are sick with COVID-19.
This open-label, single arm, phase 1 trial will assess the safety and efficacy of
convalescent plasma in severely ill, mechanically ventilated participants with pneumonia due
to COVID-19. This study will enroll adults 18 years old and older, including pregnant women.
A total of 50 eligible participants will receive 2 units of convalescent plasma collected
from ABO-compatible donors who have recovered from COVID-19. Participants will receive
convalescent plasma on Study Day 1 in addition to standard of care. Participants will be
assessed daily while hospitalized and then on Study Days 15, 22, 29, and 60. All participants
will undergo a series of safety, efficacy, and laboratory assessments. Blood samples will be
collected on Days 1 (prior to plasma administration), 3, 5, 8, 11, 15, 29, and 60.
Oropharyngeal or endotracheal samples will be collected on Days 1 (prior to plasma
administration), 3, 5, 8, 11, and 15.
Biological: COVID-19 Convalescent Plasma
Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Inclusion Criteria:
1. Adult ≥18 years of age
2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or
approved assay in any specimen collected within 72 hours prior to enrollment. Note -
An exception must be requested to the Sponsor if≥72 hours since positive test.
3. Hospitalized, on invasive mechanical ventilation or ECMO, consistent with a clinical
status assessment 8-point ordinal scale severity score of 7.
4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g.,
chest x-ray or CT scan).
5. Patient or proxy is willing and able to provide written informed consent and comply
with all protocol requirements.
Exclusion Criteria:
1. Contraindication to transfusion (e.g., severe volume overload, history of severe
allergic reaction to blood products), as judged by the investigator.
2. Clinical suspicion that the etiology of acute illness (acute decompensation) is
primarily due to a condition other than COVID-19
3. Receipt of other investigational therapy as a part of another clinical trial. a. Note:
investigational therapies used as part of clinical care, (eg, remdesivir,
hydroxychloroquine) are permissible.
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Katharine J. Bar, MD, Principal Investigator
University of Pennsylvania