COVID-19NCT04342195
Acquiring Convalescent Specimens for COVID-19 Antibodies
An observational study of COVID-19 and Coronavirus Infection, run by Columbia University at 1 site in United States.
Trial summary
Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19, Coronavirus Infection, Corona Virus Infection
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 12 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have recovered from COVID-19 infection.
Who may be able to join
- Age 18 to 65 (inclusive)
- Confirmed COVID-19 infection by a FDA-approved molecular based assay (including those under emergency use authorization) of respiratory or blood specimens;
- If symptomatic with COVID-19, must have evidence of improvement of symptoms and a duration of at least 4 weeks from the onset of symptoms to day of enrollment;
- If asymptomatic, must have a duration of at least 4 weeks from first positive molecular based COVID-19 assay to day of enrollment
Who cannot join
- <18 years or >65 years old
- No confirmed diagnosis of COVID-19
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center/NYP
New York, New York, 10032
About this study
Official title: Acquiring Convalescent Specimens to Isolate and Identify Potent Monoclonal Antibodies Against COVID-19
Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.
Read the detailed description
Coronavirus disease (COVID-19), an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused over 1,273,712 infections and over 69,458 deaths worldwide. Columbia University Irving Medical Center/NewYork-Presbyterian (CUIMC/NYP) has assembled a team of committed virologists, molecular biologists, chemists, and technologists to address this emerging threat. Monoclonal antibodies have become great additions to our therapeutic arsenal, primarily in treating cancer or autoimmune diseases. Recently, the use of monoclonal antibodies in combating infections such as respiratory syncytial virus and HIV have also become clear. In recent years, advanced cell sorting and sequencing technologies have been utilized to identify neutralizing antibodies from human B cells. This protocol will outline our approach to obtaining blood specimens from participants who are recovering from COVID-19 infection. Potential participants will be referred by health care providers from within the CUIMC/NYP system and from outside institutions. If the potential participant agrees to be contacted, study staff will call them to review the informed consent, eligibility criteria and study procedures, and set up a study visit for blood draw. Monoclonal antibodies that could potently neutralize 2019 novel coronavirus (2019-nCoV) and related coronaviruses will be isolated from these specimens. Candidate monoclonal antibodies will then be optimized and evaluated for therapeutic potential. The ultimate goal would be able to produce a monoclonal antibody that could confer protection during an outbreak or be utilized to treat patients with severe COVID disease.
- Conditions
- COVID-19, Coronavirus Infection, Corona Virus Infection
- Being tested
- Blood draw
- 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.
Blood drawProcedure or surgery
Participants will have approximately 45 ml of whole blood drawn (3 Tablespoons) drawn at the study visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of antibodies against coronaviruses isolated and identified from patient samples
The blood specimen will be proceeded into peripheral blood mononuclear cells and plasma to be stored for testing. In brief, CD27+ memory B cells that can bind to a SARS-CoV-2 S protein bait will be sorted by flow cytometry and RNA will be extracted to obtain heavy and light chain sequences. Antibody sequences will be annotated using bioinformatics approaches, and candidate sequences will be cloned. Purified antibodies will be characterized and neutralization breadth and potency against SARS-CoV-2 and other related coronaviruses will be assessed using neutralization assays.
Measured: Up to 12 months after collection visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start25 Mar 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ho, M.D,, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342195
- Sponsor's protocol ID
- AAAS9517
- Status last verified
- Jul 2022
- First submitted
- 8 Apr 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquiring Convalescent Specimens to Isolate and Identify Potent Monoclonal Antibodies Against COVID-19
- ClinicalTrials.gov ID
- NCT04342195
- Acronym / sponsor ID
- AAAS9517
- Conditions
- COVID-19, Coronavirus Infection, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 10 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.
Blood samples from participants who have recovered from COVID-19 infection will be obtained and studied. The goal of the research is to identify antibodies that have been generated by the patient to fight the COVID-19 infection. By identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.
Detailed description
Coronavirus disease (COVID-19), an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused over 1,273,712 infections and over 69,458 deaths worldwide. Columbia University Irving Medical Center/NewYork-Presbyterian (CUIMC/NYP) has assembled a team of committed virologists, molecular biologists, chemists, and technologists to address this emerging threat. Monoclonal antibodies have become great additions to our therapeutic arsenal, primarily in treating cancer or autoimmune diseases. Recently, the use of monoclonal antibodies in combating infections such as respiratory syncytial virus and HIV have also become clear. In recent years, advanced cell sorting and sequencing technologies have been utilized to identify neutralizing antibodies from human B cells. This protocol will outline our approach to obtaining blood specimens from participants who are recovering from COVID-19 infection. Potential participants will be referred by health care providers from within the CUIMC/NYP system and from outside institutions. If the potential participant agrees to be contacted, study staff will call them to review the informed consent, eligibility criteria and study procedures, and set up a study visit for blood draw. Monoclonal antibodies that could potently neutralize 2019 novel coronavirus (2019-nCoV) and related coronaviruses will be isolated from these specimens. Candidate monoclonal antibodies will then be optimized and evaluated for therapeutic potential. The ultimate goal would be able to produce a monoclonal antibody that could confer protection during an outbreak or be utilized to treat patients with severe COVID disease.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have recovered from COVID-19 infection.
Key inclusion criteria (4 listed)
- Age 18 to 65 (inclusive)
- Confirmed COVID-19 infection by a FDA-approved molecular based assay (including those under emergency use authorization) of respiratory or blood specimens;
- If symptomatic with COVID-19, must have evidence of improvement of symptoms and a duration of at least 4 weeks from the onset of symptoms to day of enrollment;
- If asymptomatic, must have a duration of at least 4 weeks from first positive molecular based COVID-19 assay to day of enrollment
Key exclusion criteria (2 listed)
- <18 years or >65 years old
- No confirmed diagnosis of COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawParticipants will have approximately 45 ml of whole blood drawn (3 Tablespoons) drawn at the study visit. | Procedure or surgery | – |
Primary outcome
Number of antibodies against coronaviruses isolated and identified from patient samples
Time frame: Up to 12 months after collection visit
The blood specimen will be proceeded into peripheral blood mononuclear cells and plasma to be stored for testing. In brief, CD27+ memory B cells that can bind to a SARS-CoV-2 S protein bait will be sorted by flow cytometry and RNA will be extracted to obtain heavy and light chain sequences. Antibody sequences will be annotated using bioinformatics approaches, and candidate sequences will be cloned. Purified antibodies will be characterized and neutralization breadth and potency against SARS-CoV-2 and other related coronaviruses will be assessed using neutralization assays.
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 20 Jul 2022.
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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.
David Ho, M.D, principal investigator
Columbia University
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 and Coronavirus Infection, run by Columbia University 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 4 inclusion and 2 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 20 Jul 2022. 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?
Number of antibodies against coronaviruses isolated and identified from patient samples (time frame: Up to 12 months after collection visit). 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 20 Jul 2022.