Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
University of Illinois at Chicago · Other
Who this trial is looking for
This trial is looking for patients aged 40 and over who are hospitalized with COVID-19. Participants will receive either convalescent plasma or fresh frozen plasma to see if it helps them recover.
Are You a Good Fit for This Trial?
You may be able to join if
I am 40 years old or older.
I am in the hospital due to COVID-19.
I have tested positive for COVID-19 within the last 72 hours.
I have symptoms like fever or cough.
I need extra oxygen to breathe.
I agree to follow the study instructions.
I consent to store samples for future tests.
You may not be able to join if
I have a known Immunoglobulin A deficiency.
I am on a ventilator.
I have had a severe transfusion reaction before.
I have a chronic lung disease requiring oxygen.
I am pregnant or breastfeeding.
I received pooled immunoglobulin in the last 30 days.
I will take another experimental COVID-19 treatment during the study.
I have severe COVID-19 disease requiring special medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Facility
City
State
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Status
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 Laboratori…
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
Contacts
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