NCT04360733

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

April 22, 2020

Last Update Submit

April 29, 2021

Conditions

SARS-CoV 2COVID

Outcome Measures

Primary Outcomes (1)

  • Immune response

    Immune response of whole blood stimulation assay with various immune activators will be measured by FACS and multiplex Assay

    4 weeks

Study Arms (4)

asymptomatic Covid-19

Patients with confirmed SARS-CoV2 PCR but no clinical symptoms

Other: Blood draw

symptomatic Covid-19

Patients with confirmed SARS-CoV2 PCR and light clinical symptoms

Other: Blood draw

severe Covid-19

Patients with confirmed SARS-CoV2 PCR and severe clinical symptoms with ICU admission

Other: Blood draw

healthy controls

Persons with negative SARS-CoV2 PCR

Other: Blood draw

Interventions

Blood drawOTHER

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

asymptomatic Covid-19healthy controlssevere Covid-19symptomatic Covid-19

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • SARS-Cov2 positive PCR

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood including Serum and Immune cells

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Eicke Latz, Prof

    Institute of Innate Immunity, Univeristy of Bonn

    STUDY DIRECTOR

Central Study Contacts

Christian Bode, MD

CONTACT

+49228287christian.bode@ukbonn.de

Folkert Steinhagen, MD

CONTACT

+49228287Folkert.Steinhagen@ukbonn.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

April 20, 2020

Primary Completion

April 1, 2022

Study Completion

September 1, 2022

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

DE(1)