Coronavirus Disease 2019 (COVID-19)NIAIDNCT04344977
Collection of Anti-SARS-CoV-2 Immune Plasma
An observational study of Coronavirus Disease 2019 (COVID-19), run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19)
- How many people
- 151 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2020to 3 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convalescent survivors of COVID-19 will be recruited at sites around the US.
Who may be able to join
- Provide written informed consent before initiation of any study procedures.
- Age greater than or equal to 18 years old and less than or equal to 70 years old.
- 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
Show all 12Show fewer
- Current anti-SARS-CoV-2 neutralizing antibody titer of at least 1:80
- Females must have a negative anti-HLA screening test
- Weight greater than or equal to110 pounds (50 kg)
- Meets FDA-approved criteria per local blood collector for plasmapheresis for plasma donation
- Adequate peripheral venous access for plasma donation (as judged by the examiner)
- Willingness to have samples stored
Who cannot join
- 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
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami Infectious Diseases Research Unit
Miami, Florida, 33136
Bloodworks Northwest
Seattle, Washington, 98104
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A Pilot Study for Collection of Anti-SARS-CoV-2 Immune Plasma
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.
Read more
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.
Read the 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.
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Keywords
- Coronavirus, COVID-19, IVIG, Convalescent plasma, Severe acute respiratory syndrome coronavirus 2
- Medical subject headings
- COVID-19, Coronavirus Infections
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of eligible donors and collection of anti-SARS-CoV-2 immune plasma
Donors screened and identified and anti-SARS-CoV-2 immune plasma collected
Measured: Screening, Days 120 or 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jun 2020
- Primary completion20 Nov 2020
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344977
- Sponsor's protocol ID
- 200081
- Other IDs
- 20-I-0081
- Acronym
- NIAID
- Status last verified
- Mar 2021
- First submitted
- 13 Apr 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Collection of Anti-SARS-CoV-2 Immune Plasma
- ClinicalTrials.gov ID
- NCT04344977
- Acronym / sponsor ID
- NIAID / 200081
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Keywords
- Coronavirus, COVID-19, IVIG, Convalescent plasma, Severe acute respiratory syndrome coronavirus 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 14 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 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convalescent survivors of COVID-19 will be recruited at sites around the US.
Key inclusion criteria (12 listed)
- Provide written informed consent before initiation of any study procedures.
- Age greater than or equal to 18 years old and less than or equal to 70 years old.
- 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:
- Current anti-SARS-CoV-2 neutralizing antibody titer of at least 1:80
- Females must have a negative anti-HLA screening test
Key exclusion criteria (8 listed)
- Any sign of active illness of any kind including COVID-19 illness (as judged by the investigator), including but not limited to:
- Participation in medical research that includes:
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
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
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 5 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019 (COVID-19), run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 12 inclusion and 8 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 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Identification of eligible donors and collection of anti-SARS-CoV-2 immune plasma (time frame: Screening, Days 120 or 240). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2021.