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Collection of Anti-SARS-CoV-2 Immune Plasma (NIAID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344977
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:

Background:

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.

Objective:

To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from COVID-19.

Eligibility:

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.

Design:

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)

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Case-Only
Time Perspective: Prospective
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


Group/Cohort
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



Primary Outcome Measures :
  1. 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
Serum, plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Convalescent survivors of COVID-19 will be recruited at sites around the US.
Criteria

INCLUSION CRITERIA:

  1. Provide written informed consent before initiation of any study procedures.
  2. Age greater than or equal to 18 years old and less than or equal to 70 years old.
  3. Subjects must not be symptomatic, must be afebrile for ≥14 days, beyond 28 days of the resolution of their acute COVID-19 illness, and must enroll within 18 months of onset of illness, and must meet at least 1 of the following:

    • History suggestive of resolved COVID-19-like illness (e.g., prior fever, dry cough, and shortness of breath). OR
    • History of positive test for SARS-CoV-2 (either serologic or RT-PCR) OR
    • Documented anti-SARSCoV-2 neutralizing antibody titer of at least 1:80
  4. Current anti-SARS-CoV-2 neutralizing antibody titer of at least 1:80
  5. Females must have a negative anti-HLA screening test
  6. Weight greater than or equal to110 pounds (50 kg)
  7. Meets FDA-approved criteria per local blood collector for plasmapheresis for plasma donation
  8. Adequate peripheral venous access for plasma donation (as judged by the examiner)
  9. Willingness to have samples stored

EXCLUSION CRITERIA:

  1. Any sign of active illness of any kind including COVID-19 illness (as judged by the investigator), including but not limited to:

    • Subjective or documented fever (greater than or equal to 38°C)
    • Dry cough
    • Shortness of breath
  2. Participation in medical research that includes:

    • Protocols that are currently ongoing or will start during the duration of this study that require more than 100 mL of blood to be given in any 8-week period of time
    • Administration of any unlicensed drug within the last 1 month or during the duration of this study, per investigation discretion
    • Administration of any unlicensed vaccine within the last 12 months or during the duration of this study.

Information from the National Library of Medicine

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


Locations
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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
Bloodworks Northwest
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04344977    
Other Study ID Numbers: 200081
20-I-0081 ( Other Identifier: NIHCC )
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Coronavirus
COVID-19
IVIG
Convalescent plasma
Severe acute respiratory syndrome coronavirus 2
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases