Convalescent Plasma Collection and Treatment in Pediatrics and Adults
Clara Health

Convalescent Plasma Collection and Treatment in Pediatrics and Adults

Sponsored by West Virginia University


Convalescent plasma (here on referred to as plasma) has been used in emergency life-threatening situations to treat infections for over 100 years. The plasma is donated by an individual that has recovered from the very same infection that another person is infected with. This plasma is enriched in the antibodies that recognize and helped the body's immune system fight off the infection.

When transfused from donor to recipient those antibodies will aid the recipient in fighting off the infection. In recent history this has been used to fight Ebola. Recently, the Federal Food and Drug Agency (FDA) made possible expedited Investigational New Drug (IND) process for plasma use in the fight against COVID19 for emergency and lifesaving uses.

About 
COVID-19

Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors.

Study type: Interventional (Clinical Trial) Estimated Enrollment: 240 participants Actual Study Start Date: April 16, 2020 Estimated Study Completion Date: March 30, 2021

Who is this study for?

Inclusion Criteria*:

Plasma donation:


Plasma Recipients:

  • Individuals of any age above 30 days of life, sex, or pregnancy status suffering from confirmed COVID19 and in rapid progression, severe or critical condition meeting the FDA IND guidelines.
  • Must have laboratory confirmed COVID19
  • Must have severe or immediately life-threatening COVID19

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

  • There are 3 basic arms to the study: mild, moderate and severe/critical severity.
  • All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression.
  • Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units.
  • There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
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Have a question?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you’ll be connected to the study team.