Convalescent Plasma as a Possible Treatment for COVID-19

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT04442191
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Convalescent plasma — BIOLOGICAL
    This study will use convalescent plasma collected from those who have previously had COVID-19 and have been shown to have cleared the infection and made antibodies against the virus.
  • Placebo — BIOLOGICAL
    The placebo arm of this study will use fresh frozen plasma that presumably does not contain antibodies against COVID-19.

Study Details

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.

Key Dates

Start date
May 5, 2020
Status verified
Jun 2020
Primary completion
May 5, 2021
Completion
May 5, 2021

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Convalescent plasma
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Oxygen supplementation [ Time Frame: 8 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612
Jesica A Herrick, MD, MS
[email protected]
312-996-1834
Jesica A Herrick, MD (PRINCIPAL_INVESTIGATOR)
Richard Novak, MD (SUB_INVESTIGATOR)
Mahesh Patel, MD (SUB_INVESTIGATOR)
Sally Campbell-Lee, MD (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of Illinois at Chicago· Chicago, IL

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