Recruiting at 1 site Phase 2 COVID-19

COVID-19 study: Convalescent plasma

Official title Convalescent Plasma as a Possible Treatment for COVID-19

ClinicalTrials.gov ID: NCT04442191

What this study is testing

What is Convalescent plasma?

This is an investigational blood product being studied as a potential treatment for COVID-19. It is designed to provide antibodies from recovered donors to help the body fight the virus.

Also referred to as Fresh Frozen Plasma.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study checks if giving plasma from recovered people helps those who are very sick with COVID-19. It also looks at whether this treatment is safe.
Who it's for
People who are currently very ill with COVID-19.
What's involved
Participants will receive an infusion of plasma. Some will get plasma from recovered patients, while others will get standard plasma. Doctors will monitor their health closely.
Time commitment
The study involves hospital stays and regular check-ups to track how the treatment works.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 40 and older

You may be able to join 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...
  • 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

You likely 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...
  • Female people who report that they are pregnant or breastfeeding
  • Receipt of pooled immunoglobulin in the past 30 days
See the full eligibility criteria
Who can join
  • 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...
  • 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
What rules you out
  • 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 people 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

The study team makes the final eligibility decision.

Where it is enrolling

  • Chicago, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.