Official Title
Acquiring Convalescent Specimens to Isolate and Identify Potent Monoclonal Antibodies Against COVID-19
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.

Recruiting
COVID-19
Coronavirus Infection
Corona Virus Infection

Procedure: Blood draw
Participants will have approximately 45 ml of whole blood drawn (3 Tablespoons) drawn at the study visit.

Eligibility Criteria

Inclusion Criteria: - 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

Exclusion Criteria: - 65 years old - No confirmed diagnosis of COVID-19

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 65 Years
Countries
United States
Locations

Columbia University Irving Medical Center/NYP
New York, New York, 10032

Recruiting

Investigator: Brett Gray

Contacts

Yang Luo, PhD
212-304-6205
yl4459@cumc.columbia.edu

David Ho, M.D,
Principal Investigator
Columbia University Irving Medical Center

Columbia University
NCT Number
MeSH Terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome