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 improves patients' health as compared to not using it in patients with pneumonia caused by SARS-CoV-2.
This open-label, randomized, controlled, phase 1 trial will assess the safety and efficacy of
convalescent plasma in severely ill, hospitalized participants with pneumonia due to
COVID-19. This study will enroll adults 18 years old and older, including pregnant women.
A total of 80 eligible participants will be randomized to receive either 2 units of
convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 and
standard of care (treatment arm) or standard of care alone (control arm). Participants in the
treatment arm will receive 2 units of convalescent plasma on Study Day 1 in addition to
standard of care.
Participants will be assessed on study Day 1 (pre-dose), 30 minutes after each unit of
plasma, on all Study Days while hospitalized, and Study Days 15, 22, 29, and 60. All
participants will undergo a series of safety and efficacy, assessments. Blood samples will be
collected on Days 1 (prior to plasma administration), 3, 8, 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
2 units of COVID-19 convalescent plasma compatible with their blood type
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 in participating facility.
4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g.,
chest x-ray or CT scan).
5. Abnormal respiratory status that is judged worse than baseline by the investigator and
as documented at any point within 24 hours prior to randomization, consistent with
ordinal scale levels 5, 6 or 7, specifically defined as:
- Room air saturation of oxygen (SaO2) < 93%, OR
- Requiring supplemental oxygen, OR
- Tachypnea with respiratory rate ≥30
6. 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. 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, Principal Investigator
University of Pennsylvania