Acquiring Convalescent Specimens for COVID-19 Antibodies

NCT04342195 | Completed

• 1 other identifier: AAAS9517
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Coronavirus Infection; Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months after collection visit

Interventions

Blood draw PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have recovered from COVID-19 infection.

You may qualify if:

• 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

You may not qualify if:

• \<18 years or \>65 years old
• No confirmed diagnosis of COVID-19

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center/NYP

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood from which peripheral blood mononuclear cells (PBMCs) and plasma will be processed.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Ho, M.D,

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: March 25, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

US (1)