Actively Recruiting

Phase 2
Age: 40Years +
All Genders
NCT04442191

Convalescent Plasma as a Possible Treatment for COVID-19

Led by University of Illinois at Chicago · Updated on 2020-06-22

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Convalescent Plasma as a Possible Treatment for COVID-19

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Symptomatic infection with fever, cough, dyspnea, or tachypnea greater than 22 breaths/min
  • Need for supplemental oxygen between 1-5 liters/min by nasal cannula to maintain oxygen saturations above 92%
  • Consents to comply with all protocol requirements
  • Agrees to storage of specimens for future testing
Not Eligible

You will not qualify if you...

  • Known Immunoglobulin A deficiency
  • Currently on a ventilator
  • Past severe transfusion reaction including TRALI or anaphylaxis
  • Baseline need for supplemental oxygen due to chronic lung disease or history of moderate-to-severe asthma or emphysema
  • Female subjects who are pregnant or breastfeeding
  • Receipt of pooled immunoglobulin in past 30 days
  • Willingness to avoid other experimental COVID-19 treatments until 28-day follow-up
  • Treatment with Remdesivir started more than 24 hours before first convalescent plasma dose
  • Severe COVID-19 disease requiring vasopressors or diagnosis of Acute Respiratory Distress Syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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