COVID-19NCT04360278
Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19
An observational study of COVID-19, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community donors who have recovered from COVID-19, or have been immunized against SARS-CoV-2.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- COVID-19
- Keywords
- Titer, Antibodies, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Plasma Donors | Persons who have recovered from COVID-19 or have been immunized against SARS-CoV-2 who meet criteria to donate plasma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of convalescent plasma
Successful collection of convalescent or immunized donor plasma.
Measured: 240 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start21 Apr 2020
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kamille A West-Mitchell, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360278
- Sponsor's protocol ID
- 200092
- Other IDs
- 20-CC-0092
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .aa
Publications
Gedda MR, Danaher P, Shao L, Ongkeko M, Chen L, Dinh A, Thioye Sall M, Reddy OL, Bailey C, Wahba A, Dzekunova I, Somerville R, De Giorgi V, Jin P, West K, Panch SR, Stroncek DF. Longitudinal transcriptional analysis of peripheral blood leukocytes in COVID-19 convalescent donors. J Transl Med. 2022 Dec 12;20(1):587. doi: 10.1186/s12967-022-03751-7.
PubMed 36510222De Giorgi V, West KA, Henning AN, Chen LN, Holbrook MR, Gross R, Liang J, Postnikova E, Trenbeath J, Pogue S, Scinto T, Alter HJ, Cantilena CC. Naturally Acquired SARS-CoV-2 Immunity Persists for Up to 11 Months Following Infection. J Infect Dis. 2021 Oct 28;224(8):1294-1304. doi: 10.1093/infdis/jiab295.
PubMed 34089610
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Collection From Convalescent and/or Immunized Donors for the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04360278
- Acronym / sponsor ID
- 200092
- Conditions
- COVID-19
- Keywords
- Titer, Antibodies, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma Donors | – | –Persons who have recovered from COVID-19 or have been immunized against SARS-CoV-2 who meet criteria to donate plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community donors who have recovered from COVID-19, or have been immunized against SARS-CoV-2.
Key inclusion criteria (14 listed)
- 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:
- For COVID-19 convalescent subjects, the following criteria must be met:
- For vaccinated subjects, the following criteria must be met:
Key exclusion criteria (16 listed)
- 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:
- Antibiotics within the prior 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection of convalescent plasma
Time frame: 240 days
Successful collection of convalescent or immunized donor plasma.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 36510222Gedda MR, Danaher P, Shao L, Ongkeko M, Chen L, Dinh A, Thioye Sall M, Reddy OL, Bailey C, Wahba A, Dzekunova I, Somerville R, De Giorgi V, Jin P, West K, Panch SR, Stroncek DF. Longitudinal transcriptional analysis of peripheral blood leukocytes in COVID-19 convalescent donors. J Transl Med. 2022 Dec 12;20(1):587. doi: 10.1186/s12967-022-03751-7.
- Derived from this study: PubMed 34089610De Giorgi V, West KA, Henning AN, Chen LN, Holbrook MR, Gross R, Liang J, Postnikova E, Trenbeath J, Pogue S, Scinto T, Alter HJ, Cantilena CC. Naturally Acquired SARS-CoV-2 Immunity Persists for Up to 11 Months Following Infection. J Infect Dis. 2021 Oct 28;224(8):1294-1304. doi: 10.1093/infdis/jiab295.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. .aa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamille A West-Mitchell, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of convalescent plasma (time frame: 240 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360278, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.