COVID-19DIRECTORNCT04655521
Dynamics of the Immune Response to COVID-19 / Infection by SARS-CoV-2
An observational study of COVID-19 and SARS-CoV-2, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2, Viral Infection
- How many people
- 173 participants
- Where
- 1 siteGermany
- Study dates
- 2 Dec 2020to 30 Sep 2021
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Eligible subjects 3 months and older with suspicion of COVID-19 that present to the hospital due to suspected COVID-19. Controls with respiratory tract infection (Non-COVID-19) and healthy controls
Who may be able to join
- signed informed consent
- confirmed infection with SARS-CoV-2 (except for the controls)
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Dynamics of the Immune Response to Infection by SARS Coronavirus 2
To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.
- Conditions
- COVID-19, SARS-CoV-2, Viral Infection
- Medical subject headings
- COVID-19, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | Not described | |
| Healthy controls | Not described | |
| Non-COVID-19 patients with respiratory tract infection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential expression of biomarkers between COVID-19 and controls
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.
Measured: up to 90 days
Differential expression of biomarkers between severe and non-severe COVID-19
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, who require more extensive medical intervention (i.e., exhibit severe symptoms), i.e. severe infection vs. non-severe infection
Measured: up to 90 days
Correlation of biomarkers with disease severity
Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration for predicting disease severity in patients with COVID-19, where measures of severity include ICU admission, respiratory failure, mechanical ventilation, septic shock, non-respiratory organ failure, and mortality.
Measured: up to 90 days
Secondary outcomes (3)
Biomarkers depending on therapy
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy.
Measured: up to 90 days
Biomarkers depending on bacterial co-infection
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection.
Measured: up to 90 days
Correlation of biomarkers with viral load
Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start2 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- MeMed Diagnostics Ltd.
- Responsible party
- Principal investigator, Cihan Papan, Universität des Saarlandes
- Investigators
- Cihan Papan, MD, Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655521
- Sponsor's protocol ID
- 109/20
- Acronym
- DIRECTOR
- Status last verified
- Nov 2021
- First submitted
- 2 Dec 2020
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.
PubMed 25785720van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22.
PubMed 28012942Tegethoff SA, Danziger G, Kuhn D, Kimmer C, Adams T, Heintz L, Metz C, Reifenrath K, Angresius R, Mang S, Rixecker T, Becker A, Geisel J, Jentgen C, Seiler F, Reichert MC, Frohlich F, Meyer S, Rissland J, Ewen S, Wagenpfeil G, Last K, Smola S, Bals R, Lammert F, Becker SL, Krawczyk M, Lepper PM, Papan C. TNF-related apoptosis-inducing ligand, interferon gamma-induced protein 10, and C-reactive protein in predicting the progression of SARS-CoV-2 infection: a prospective cohort study. Int J Infect Dis. 2022 Sep;122:178-187. doi: 10.1016/j.ijid.2022.05.051. Epub 2022 May 25.
PubMed 35643306
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dynamics of the Immune Response to Infection by SARS Coronavirus 2
- ClinicalTrials.gov ID
- NCT04655521
- Acronym / sponsor ID
- DIRECTOR / 109/20
- Conditions
- COVID-19, SARS-CoV-2, Viral Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- MeMed Diagnostics Ltd.
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 7 Dec 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 evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | – |
| Healthy controls | – | – |
| Non-COVID-19 patients with respiratory tract infection | – | – |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible subjects 3 months and older with suspicion of COVID-19 that present to the hospital due to suspected COVID-19. Controls with respiratory tract infection (Non-COVID-19) and healthy controls
Key inclusion criteria (2 listed)
- signed informed consent
- confirmed infection with SARS-CoV-2 (except for the controls)
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differential expression of biomarkers between COVID-19 and controls
Time frame: up to 90 days
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.
Differential expression of biomarkers between severe and non-severe COVID-19
Time frame: up to 90 days
Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, who require more extensive medical intervention (i.e., exhibit severe symptoms), i.e. severe infection vs. non-severe infection
Correlation of biomarkers with disease severity
Time frame: up to 90 days
Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration for predicting disease severity in patients with COVID-19, where measures of severity include ICU admission, respiratory failure, mechanical ventilation, septic shock, non-respiratory organ failure, and mortality.
3 secondary outcomes
Biomarkers depending on therapy
Time frame: up to 90 days
Biomarkers depending on bacterial co-infection
Time frame: up to 90 days
Correlation of biomarkers with viral load
Time frame: up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Background: PubMed 25785720Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.
- Background: PubMed 28012942van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22.
- Derived from this study: PubMed 35643306Tegethoff SA, Danziger G, Kuhn D, Kimmer C, Adams T, Heintz L, Metz C, Reifenrath K, Angresius R, Mang S, Rixecker T, Becker A, Geisel J, Jentgen C, Seiler F, Reichert MC, Frohlich F, Meyer S, Rissland J, Ewen S, Wagenpfeil G, Last K, Smola S, Bals R, Lammert F, Becker SL, Krawczyk M, Lepper PM, Papan C. TNF-related apoptosis-inducing ligand, interferon gamma-induced protein 10, and C-reactive protein in predicting the progression of SARS-CoV-2 infection: a prospective cohort study. Int J Infect Dis. 2022 Sep;122:178-187. doi: 10.1016/j.ijid.2022.05.051. Epub 2022 May 25.
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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.
Cihan Papan, MD principal investigator
Universität des Saarlandes
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 COVID-19 and SARS-CoV-2, run by Universität des Saarlandes 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 2 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: finished, as of the sponsor's last update on 24 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential expression of biomarkers between COVID-19 and controls (time frame: up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655521, which also lists 3 linked publications.
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 24 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.