Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19

COVID-19 Clinical Trial

Official title: Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19

Status Completed

Clinical Trial Summary

Background:

The Coronavirus disease 2019 (COVID-19) pandemic is a major public health issue. Researchers want to collect plasma from people who have recovered from COVID-19, and use this plasma to treat people who are sick with the disease. The plasma will have antibodies against the virus that causes COVID-19. Persons who have received a COVID-19 vaccine may also donate plasma that contains antibodies against the virus if they meet criteria according to the FDA.

Objective:

To collect plasma from people who have recovered from COVID-19 or have been vaccinated against the coronavirus that causes COVID-19, so that the plasma can be used to treat people with the disease.

Eligibility:

Adults ages 18 and older who have been diagnosed with, and have recovered from, COVID-19.

Design:

Participants will be screened with a physical exam, medical history, and blood sample. Their pulse, blood pressure, and temperature will be taken. Their height and weight will be recorded.

Participants will donate plasma. It will be collected through whole blood donation or through apheresis.

For whole blood donation, a needle will be placed in the participant s arm vein. Blood will be withdrawn.

For apheresis, a needle will be placed in the participant s arm vein. Blood will be withdrawn. A machine will separate the plasma from the red cells. The plasma will be removed, and the rest of the cells will be returned to the participant either through the same needle or through a needle in their other arm.

Participants will have 3 to 20 plasma donations.

Participation will last up to 3 years.

Clinical Trial Description

Emerging infectious diseases such as the Coronavirus disease 2019 (COVID-19) pandemic cause substantial morbidity and mortality. During the early emergent phases of such diseases, there is often no vaccine to prevent infection, nor specific therapeutic agent to treat the disease. The objective of this protocol is the collection of immune plasma from persons post-recovery from COVID-19 or vaccination against SARS-CoV-2. This plasma may potentially be used in the treatment or prophylaxis of active COVID-19 under other protocols.

Candidates will be screened for eligibility to participate in plasma donations and their blood levels of antibodies to SARS-CoV-2. Enrolled subjects will receive a baseline physical and laboratory examination. Subjects with sufficient anti-SARS-CoV-2 antibody titers who meet standard blood bank criteria for plasma donation will then be scheduled for plasma collections. Plasmapheresis is the preferred method of collection, with up to 800 mL of plasma collected per donation depending on the weight of the donor. Collected immune plasma will be tested for blood-borne pathogens, and stored according to standard blood bank procedures. The scope of this protocol is limited to collection of plasma from subjects with sufficiently high anti-SARS-CoV-2 antibody titer. Any administration of convalescent immune plasma to subjects will be performed under a separate protocol. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04360278
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: April 21, 2020
• Completion date: October 5, 2022