Convalescent Plasma for COVID-19

This study is looking at whether convalescent plasma can help people sick with COVID-19. Convalescent plasma comes from people who have recovered from COVID-19 and have antibodies (proteins that fight infection) against the virus. You might be able to join if you are 40 or older, admitted to the University of Illinois Hospital (UIC) for COVID-19, and have tested positive for the virus within the last 72 hours. The study will compare patients who receive convalescent plasma to those who receive a placebo (fresh frozen plasma without COVID-19 antibodies). Researchers will measure how much oxygen support you need after 8 days to see if the treatment is working. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This study is an interventional study with a comparison group. It plans to enroll 50 participants.
What's involved
If you join, you will have a symptom screen, physical exam, and your medical chart data will be reviewed. The study will track your vital signs and oxygen status.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring oxygen supplementation is at 8 days.

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NCT04442191

Convalescent Plasma as a Possible Treatment for COVID-19

Recruiting
PHASE2Ages 40+InterventionalTreatment
University of Illinois at Chicago
~50 participants
Updated 2020-06-22 on ClinicalTrials.gov
What's tested:Convalescent plasmaPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oxygen supplementation
Measured over 8 days
COVID-19
1 sites across 1 states
Illinois1

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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
Patients with severe disease due to COVID-19, as manifested by a need for vasopressors, and/or diagnosis of Acute Respiratory Distress Syndrome
  • Oxygen supplementation8 days

    The primary endpoint will be clinical response at 8 days, defined as no need for oxygen supplementation for the previous 24 hours.