What this study is
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.
What's being tested
- Convalescent plasma
Intervention · BIOLOGICAL
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.
- Placebo
Intervention · BIOLOGICAL
The placebo arm of this study will use fresh frozen plasma that presumably does not contain antibodies against COVID-19.
Study details
- Official title
- 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
- Sponsor
- University of Illinois at Chicago
- Conditions
- COVID-19
- Enrolling
- 50 people
- Starts
- 2020-05-05
- Est. completion
- 2021-05-05
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Illinois at Chicago
Chicago, Illinois, United States
- Jesica A Herrick, MD, MS · Contact312-996-1834Christe5@uic.edu
- Jesica A Herrick, MD · Principal investigator
- Richard Novak, MD · Sub-investigator
- Mahesh Patel, MD · Sub-investigator
- Sally Campbell-Lee, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of Illinois at Chicago
Study ID 2020-0441
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.