This study is NOT currently recruiting participants.
Number
20-CC-0092
Sponsoring Institute
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Children
Keywords
Titer; Antibodies; Natural History
Recruitment Keyword(s)
None
Condition(s)
COVID-19
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
NIH Clinical Center
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 Blood will be withdrawn.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 Blood will be withdrawn.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.
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INCLUSION CRITERIA: -Ability of subject to understand, ask questions, and the willingness to sign the written informed consent document -Age >=18 years -Ability to meet blood donor eligibility criteria as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards and DTM SOP, including: --Weight >=110 pounds (50 kg) --Adequate peripheral venous access for plasma donation (as judged by the examiner) --Vital signs (with exceptions as acceptable per DTM SOP) -For COVID-19 convalescent subjects, the following criteria must be met: --Prior diagnosis of COVID-19 documented by a laboratory test or by physician attestation --Complete resolution of symptoms for at least 10 days prior to donation. --Donors with residual loss of taste/smell are acceptable as long as they have no acute symptoms of COVID-19 -For vaccinated subjects, the following criteria must be met: --Subjects must meet FDA donor eligibility criteria to donate convalescent plasma -Willingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high -Willingness to have samples stored for clinical and/or genetic research testing EXCLUSION CRITERIA: -Patients who cannot give proper informed consent due to inability to understand the nature of the proposed therapy and attendant risk -Age under 18 years -Females must not be pregnant (per routine blood donor criteria) -Any sign of active infection, including but not limited to: --Subjective or documented fever (>37.5 (Infinite)C) --Cough --Shortness of breath --Diarrhea -Antibiotics within the prior 48 hours -Considered immune suppressed for example current use of oral or parenteral steroids, highdose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs -Permanent deferral from blood donation as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards, and DTM SOP -Participation in medical research outside DTM that includes: --Protocols that are currently ongoing or will start during the duration of this study that require more than 500 mL of blood to be given in any 8-week period of time -Total plasma protein level < 6.0 g/dL -Unwillingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high -Unwillingness to have samples stored for clinical and/or genetic research testing
-Ability of subject to understand, ask questions, and the willingness to sign the written informed consent document
-Age >=18 years
-Ability to meet blood donor eligibility criteria as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards and DTM SOP, including:
--Weight >=110 pounds (50 kg)
--Adequate peripheral venous access for plasma donation (as judged by the examiner)
--Vital signs (with exceptions as acceptable per DTM SOP)
-For COVID-19 convalescent subjects, the following criteria must be met:
--Prior diagnosis of COVID-19 documented by a laboratory test or by physician attestation
--Complete resolution of symptoms for at least 10 days prior to donation.
--Donors with residual loss of taste/smell are acceptable as long as they have no acute symptoms of COVID-19
-For vaccinated subjects, the following criteria must be met:
--Subjects must meet FDA donor eligibility criteria to donate convalescent plasma
-Willingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high
-Willingness to have samples stored for clinical and/or genetic research testing
EXCLUSION CRITERIA:
-Patients who cannot give proper informed consent due to inability to understand the nature of the proposed therapy and attendant risk
-Age under 18 years
-Females must not be pregnant (per routine blood donor criteria)
-Any sign of active infection, including but not limited to:
--Subjective or documented fever (>37.5 (Infinite)C)
--Cough
--Shortness of breath
--Diarrhea
-Antibiotics within the prior 48 hours
-Considered immune suppressed for example current use of oral or parenteral steroids, highdose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs
-Permanent deferral from blood donation as defined in the FDA Code of Federal Regulations 21 CFR 630, AABB Standards, and DTM SOP
-Participation in medical research outside DTM that includes:
--Protocols that are currently ongoing or will start during the duration of this study that require more than 500 mL of blood to be given in any 8-week period of time
-Total plasma protein level < 6.0 g/dL
-Unwillingness to engage in repeat plasma collections for a 120-day period with possible extension per FDA guidance, provided anti-SARS-CoV-2 titers remain sufficiently high
-Unwillingness to have samples stored for clinical and/or genetic research testing
Principal Investigator
Referral Contact
For more information: