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Antibody Therapy

Convalescent Plasma as a Possible Treatment for COVID-19

Phase 2
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days

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 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.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxygen supplementation
Secondary study objectives
28-day and in-hospital mortality rate
C-reactive Protein (CRP)
D-Dimer
+9 more
Other study objectives
Safety endpoint two: adverse events
Safety endpoint: Severe transfusion reaction

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Convalescent plasmaExperimental Treatment1 Intervention
This study will utilize convalescent plasma from donors recovered from infection with SARS-CoV-2 (which causes COVID-19) with neutralizing antibody titers \>1:64.
Group II: PlaceboPlacebo Group1 Intervention
Placebo utilized in this study will include Fresh Frozen Plasma collected before the COVID-19 pandemic began. As an extra control, some of this plasma will be saved and tested for COVID-19 antibodies to ensure they are not present.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
COVID-19 convalescent plasma
Not yet FDA approved

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,736 Total Patients Enrolled
~9 spots leftby Dec 2025