Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection
Clara Health

Convalescent Plasma for Hospitalized Subjects With COVID-19

Sponsored by Hackensack Meridian Health


This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.

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?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 55 participants Primary Purpose: Treatment Official Title: Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection Estimated Study Start Date: April 2020 Estimated Study Completion Date: April 2021

Who is this study for?

Donor Eligibility Criteria*:

  • Age 18-60
  • A history of a positive nasopharyngeal swab for COVID-19
  • At least 14 days from resolution of COVID-19-associated symptoms

Recipient Eligibility Criteria:*: Recipients age >18 years old, are assigned to one of two clinical tracks, track 2 or 3, based on COVID-19 disease severity.

Track 2: - Hospitalized, moderate symptoms requiring medical care for COVID-19 infection - Symptoms may include fever, dyspnea, dehydration among others

Track 3: - Requiring mechanical ventilation for the care of COVID-19 infection

Recipient exclusion Criteria*:

  • COVID-19-associated acute kidney injury requiring dialysis

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

What should I expect?

  • Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
  • The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).

Experimental: Convalescent Plasma Fresh plasma will be infused one time to hospitalized patients with COVID-19 infection

Have questions or need help?

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 team.