Precision Immunology to Determine the Immune Response in Patients With COVID-19

Precision Immunology Approach to Better Understand the Divergent Host Responses Towards Infection With SARS-CoV-2

To better understand the immune response to SARS-CoV-2 infection, we devised a precision immunology approach to systematically study the immune function of different patient cohorts

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV 2; COVID
• Intervention / Treatment: Other: Blood draw

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Christian Bode, MD; Phone Number: 14119 +49228287; Email: christian.bode@ukbonn.de
• Study Contact Backup: Name: Folkert Steinhagen, MD; Phone Number: 14114 +49228287; Email: Folkert.Steinhagen@ukbonn.de

Study Locations

• Germany
  • Bonn, Germany, 53127
    • Recruiting
    • University Hospital Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with different severity of COVID-19. From asymptomatic to critical illness

Description

Inclusion Criteria:

• SARS-Cov2 positive PCR

Exclusion Criteria:

• pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
asymptomatic Covid-19; Patients with confirmed SARS-CoV2 PCR but no clinical symptoms	Other: Blood draw; serial blood draw and subsequent deep immune phenotyping analysis, (ii.) immune activation assays, (iii.) transcriptome and (iv.) epigenome analysis in an overarching (v.) bioinformatics data analysis
symptomatic Covid-19; Patients with confirmed SARS-CoV2 PCR and light clinical symptoms	Other: Blood draw; serial blood draw and subsequent deep immune phenotyping analysis, (ii.) immune activation assays, (iii.) transcriptome and (iv.) epigenome analysis in an overarching (v.) bioinformatics data analysis
severe Covid-19; Patients with confirmed SARS-CoV2 PCR and severe clinical symptoms with ICU admission	Other: Blood draw; serial blood draw and subsequent deep immune phenotyping analysis, (ii.) immune activation assays, (iii.) transcriptome and (iv.) epigenome analysis in an overarching (v.) bioinformatics data analysis
healthy controls; Persons with negative SARS-CoV2 PCR	Other: Blood draw; serial blood draw and subsequent deep immune phenotyping analysis, (ii.) immune activation assays, (iii.) transcriptome and (iv.) epigenome analysis in an overarching (v.) bioinformatics data analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune response	Immune response of whole blood stimulation assay with various immune activators will be measured by FACS and multiplex Assay	4 weeks

Collaborators and Investigators

• Sponsor: University of Bonn
• Investigators: Study Director: Eicke Latz, Prof, Institute of Innate Immunity, Univeristy of Bonn

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2020
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BOST-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No