Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-04 @ 3:36 AM
Study NCT ID:
NCT04342195
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2020-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acquiring Convalescent Specimens for COVID-19 Antibodies
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Acquiring Convalescent Specimens to Isolate and Identify Potent Monoclonal Antibodies Against COVID-19
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: