Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19
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|ClinicalTrials.gov Identifier: NCT04360278|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : June 28, 2022
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.
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.
Adults ages 18 and older who have been diagnosed with, and have recovered from, COVID-19.
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 Blood will be withdrawn.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 Blood will be withdrawn.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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19|
|Actual Study Start Date :||April 21, 2020|
|Estimated Primary Completion Date :||April 14, 2030|
|Estimated Study Completion Date :||April 14, 2030|
Persons who have recovered from COVID-19 or have been immunized against SARS-CoV-2 who meet criteria to donate plasma.
- Collection of convalescent plasma [ Time Frame: 240 days ]Successful collection of convalescent or immunized donor plasma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360278
|Contact: Sarah Pogue, R.N.||(301) email@example.com|
|Contact: Kamille A West, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Kamille A West, M.D.||National Institutes of Health Clinical Center (CC)|