SARS-CoV 2NCT04360733
Precision Immunology to Determine the Immune Response in Patients With COVID-19
An observational study of SARS-CoV 2 and COVID, run by University of Bonn at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV 2, COVID
- What is being tested?
- Blood draw
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2020to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with different severity of COVID-19. From asymptomatic to critical illness
Who may be able to join
- SARS-Cov2 positive PCR
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, 53127
Chrisitan Bode, MD, +4922828714119, christian.bode@ukb.uni-bonn.de
About this study
Official title: 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
- Conditions
- SARS-CoV 2, COVID
- Being tested
- Blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| asymptomatic Covid-19 | Patients with confirmed SARS-CoV2 PCR but no clinical symptoms Receives: Other: Blood draw | |
| symptomatic Covid-19 | Patients with confirmed SARS-CoV2 PCR and light clinical symptoms Receives: Other: Blood draw | |
| severe Covid-19 | Patients with confirmed SARS-CoV2 PCR and severe clinical symptoms with ICU admission Receives: Other: Blood draw | |
| healthy controls | Persons with negative SARS-CoV2 PCR Receives: Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response
Immune response of whole blood stimulation assay with various immune activators will be measured by FACS and multiplex Assay
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Apr 2020
- Primary completionApr 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Bode, University of Bonn
- Investigators
- Eicke Latz, Prof, Study director, Institute of Innate Immunity, Univeristy of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360733
- Sponsor's protocol ID
- BOST-03
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2020
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Immunology Approach to Better Understand the Divergent Host Responses Towards Infection With SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04360733
- Acronym / sponsor ID
- BOST-03
- Conditions
- SARS-CoV 2, COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| asymptomatic Covid-19 | – | Other: Blood drawPatients with confirmed SARS-CoV2 PCR but no clinical symptoms |
| symptomatic Covid-19 | – | Other: Blood drawPatients with confirmed SARS-CoV2 PCR and light clinical symptoms |
| severe Covid-19 | – | Other: Blood drawPatients with confirmed SARS-CoV2 PCR and severe clinical symptoms with ICU admission |
| healthy controls | – | Other: Blood drawPersons with negative SARS-CoV2 PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with different severity of COVID-19. From asymptomatic to critical illness
Key inclusion criteria (1 listed)
- SARS-Cov2 positive PCR
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawserial 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 | Other | asymptomatic Covid-19, healthy controls, severe Covid-19, symptomatic Covid-19 |
Primary outcome
Immune response
Time frame: 4 weeks
Immune response of whole blood stimulation assay with various immune activators will be measured by FACS and multiplex Assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eicke Latz, Prof study director
Institute of Innate Immunity, Univeristy of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2 and COVID, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Bode, MD (+49228287 ext. 14119, christian.bode@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.