Collection of Anti-SARS-CoV-2 Immune Plasma (NIAID)
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|ClinicalTrials.gov Identifier: NCT04344977|
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : March 5, 2021
The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild to moderate respiratory illness. But it can also be more severe and even lead to death. There is no vaccine to prevent SARS-CoV-2 infection. There is also no therapy to treat COVID-19. Researchers want to collect plasma from adults who have recovered from COVID-19, which may help them develop treatments.
To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from COVID-19.
Males and females ages 18 to 70 who have a history of COVID-19 like illness or positive test for SARS-CoV-2, and have a minimum level of SARS-CoV-2 antibodies as specified by the study.
This study consists of 2 parts: 1) screening for SARS-CoV-2 antibody titer and eligibility to donate plasma and 2) plasma collection by apheresis. Study sites may participate in 1 part alone (either screening or plasma collection only) or both parts (screening and plasma collection).
For screening part: Participants will be screened for their eligibility to join this research study with a medical history and physical exam. Their vital signs (blood pressure, heart rate, temperature, respiration rate) will be taken. Their weight and height will be recorded. They will give a blood sample for clinical laboratory tests of their general health and a research test for SARS-CoV-2 antibodies. They will discuss their history of COVID-19-like illness and any testing for SARS-CoV-2. They will be evaluated for their ability to donate plasma.
For plasma collection part: Subjects meeting criteria for plasma donation and found to have high neutralizing antibody titers and who plan to donate plasma under this part of the study will be scheduled for 1 (and up to 20) plasma collection sessions. These will occur no less than 7 days apart.
Prior to each donation, participants will have a brief physical exam and complete a donor history questionnaire. They will be asked about any current SARS-CoV-2 infection symptoms.
At each donation, plasma will be taken through a standard apheresis procedure. For this, blood will be withdrawn through a needle placed in the participant's arm vein. A machine will separate the plasma from the red cells. The red cells will be returned to the participant, either through the same needle or through a second needle in the other arm.
Participation may last up to 240 days.
|Condition or disease|
|Coronavirus Disease 2019 (COVID-19)|
Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent infection with SARS-CoV-2 or therapeutic agent to treat COVID-19. The objective of this protocol is the identification of eligible donors and collection of anti-SARSCoV-2 immune plasma from convalescent survivors of COVID-19 illness.
Potential subjects will be screened for eligibility to participate in plasma donations and their blood measured for antibodies to SARS-CoV-2. Enrolled subjects will receive a baseline physical and laboratory examination. Subjects with high SARS-CoV-2 neutralizing antibody titers who meet standard blood bank criteria for plasma donation will then be scheduled for plasma collection sessions. Following testing of the collected plasma for potential pathogens, this plasma may be used and/or converted into an intravenous immunoglobulin (IVIG) preparation for further study.
|Study Type :||Observational|
|Actual Enrollment :||151 participants|
|Official Title:||A Pilot Study for Collection of Anti-SARS-CoV-2 Immune Plasma|
|Actual Study Start Date :||June 1, 2020|
|Actual Primary Completion Date :||November 20, 2020|
|Actual Study Completion Date :||March 3, 2021|
Convalescent survivors of COVID-19
Convalescent survivors of COVID-19: history of COVID-19 like illness or positive test for SARS-CoV-2 and has the protocol-specified minimum anti-SARS-CoV-2 neutralizing antibody titer
- Identification of eligible donors and collection of anti-SARS-CoV-2 immune plasma [ Time Frame: Screening, Days 120 or 240 ]Donors screened and identified and anti-SARS-CoV-2 immune plasma collected
Biospecimen Retention: Samples Without DNA
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): NCT04344977
|United States, California|
|Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center|
|Torrance, California, United States, 90502|
|United States, Florida|
|University of Miami Infectious Diseases Research Unit|
|Miami, Florida, United States, 33136|
|United States, Washington|
|Seattle, Washington, United States, 98104|