Infusion of Convalescent Plasma for the Treatment of Patients Infected With Severe Acute Respiratory Syndrome-Coronavirus-2 (COVID-19): A Double-blinded, Placebo-controlled, Proof-of-concept Study
University of Illinois at Chicago
Summary
Patients who are ill with COVID-19 may benefit from receiving convalescent plasma infusions containing antibodies from donors who have recovered from the disease and are proven to no longer be infected. Given the current public health emergency due to COVID-19, the FDA has recently fast-tracked the use of convalescent plasma. The purpose for this study is to assess if convalescent plasma collected from donors previously infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, can provide clinical benefit to those acutely ill with the virus and to evaluate if such treatment is safe. There will be two arms in the interventional study, where subjects will either be treated with convalescent plasma or fresh frozen plasma in a randomized and blinded manner. As an additional comparison, the clinical course of subjects enrolled during the period of the study who do not receive an alternative treatment for COVID-19 will be assessed.
Description
Study Design and Procedures - Comparison group (no-treatment control) 1. Subjects will be identified by reviewing a REDCap database containing the list of all patients at the University of Illinois at Chicago Hospital (UIC) who were tested for COVID-19. Using these data, the investigators will identify those subjects who are \>40 years old, were admitted to the hospital during the period of the study, otherwise met all of the inclusion and exclusion criteria for the infusion arm of the study but were not enrolled and did not receive any medications for treatment of COVID-19 (were treated with…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
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% * Consen…
Interventions
- BiologicalConvalescent plasma
This study will use convalescent plasma collected from those who have previously had COVID-19 and have been shown to have cleared the infection and made antibodies against the virus.
- BiologicalPlacebo
The placebo arm of this study will use fresh frozen plasma that presumably does not contain antibodies against COVID-19.
Location
- University of Illinois at ChicagoChicago, Illinois