Convalescent Plasma as a Possible Treatment for COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Patients 40 years-old and over who are admitted to the University of Illinois Hospital (UIC) due to COVID-19
- Positive oropharyngeal and/or nasopharyngeal swab test for SARS-CoV-2 by RT-PCR within the preceding 72 hours (performed by University of Illinois Hospital Laboratories or, if performed elsewhere, documented in the patient's UIC medical record)
- Symptomatic infection with any of the following: fever, cough, dyspnea, or tachypnea > 22 breaths/min
- Need for supplemental oxygen, between 1-5 liters/minute by nasal canula, to maintain O2 saturations >92%
- Consents to comply with all protocol requirements
- Agrees to storage of specimens for future testing
Exclusion Criteria:
- Patients with known Immunoglobulin A deficiency (high risk of severe or fatal anaphylactic reactions)
- Patients who are on a ventilator
- Patients with past history of severe transfusion reaction including transfusion-related acute lung injury (TRALI) or anaphylaxis
- Patients with a baseline requirement for supplemental oxygen due to chronic lung disease or with known history of either moderate-to-severe asthma or emphysema.
- Female subjects who report that they are pregnant or breastfeeding
- Receipt of pooled immunoglobulin in the past 30 days
Patients must be willing to not take any another alternative experimental treatment for COVID-19 from the time they undergo enrollment until the 28-day follow-up phone call
•. Participants who are being treated with Remdesivir and have had their first dose of Remdesivir greater than 24 hours prior to the time they will receive their first dose of convalescent plasma
- Patients with severe disease due to COVID-19, as manifested by a need for vasopressors, and/or diagnosis of Acute Respiratory Distress Syndrome
Sites / Locations
- University of Illinois at ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Convalescent plasma
Placebo
This study will utilize convalescent plasma from donors recovered from infection with SARS-CoV-2 (which causes COVID-19) with neutralizing antibody titers >1:64.
Placebo utilized in this study will include Fresh Frozen Plasma collected before the COVID-19 pandemic began. As an extra control, some of this plasma will be saved and tested for COVID-19 antibodies to ensure they are not present.