Status:
RECRUITING
Convalescent Plasma as a Possible Treatment for COVID-19
Lead Sponsor:
University of Illinois at Chicago
Conditions:
COVID-19
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 infecte...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 5 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04442191
Start Date
May 5 2020
End Date
May 5 2021
Last Update
June 22 2020
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612