COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, MortalityCytomegalovirNCT05419206
The Relationship Between CMV* Reactivation and Anti-cytokine Treatment in Critical COVID-19 Patients
An observational study of COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality, run by Ramazan Gozukucuk at 1 site in Turkey (Türkiye).
Trial summary
The risk of secondary infection is high in critical patients hospitalized with the diagnosis of COVID-19. Immunosuppressive treatments are commonly used in critical COVID-19 patients, and immune dysfunction and CMV reactivation can be unnoticed in these patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality
- What is being tested?
- CMV DNA analysis
- How many people
- 167 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 30 May 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The mean age of the patients was 59.2 (26-91 years), 63.7 years for women, and 58.6 years for men. The study included 167 critical and/or intensive care patients, 24 of whom were female (14%), and 143 of whom were men.
Who may be able to join
- Critically ill patients over the age of 18 diagnosed with COVID-19 and patients followed in the intensive care unit.
Who cannot join
- Patients under the age of 18 with a mild/moderate course of COVID-19,
- CMV PCR positive before anti-cytokine treatment,
- patients who underwent hematopoietic stem cell transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Infectious Disease and Clinical Microbiology
The risk of secondary infection is high in critical patients hospitalized with the diagnosis of COVID-19. Immunosuppressive treatments are commonly used in critical COVID-19 patients, and immune dysfunction and CMV reactivation can be unnoticed in these patients.
Read the detailed description
The records of critical patients were reviewed retrospectively. Whether these patients used tocilizumab and/or anakinra and their relationship with CMV reactivation were examined. Furthermore, the relationship between CMV reactivation and mortality and anti-cytokine treatment in patients was also examined. A total of 167 critical COVID-19 patients were included in the study, of which 38 (22.7%) were found to be CMV DNA positive. CMV positivity in patients treated with anti-cytokines (31.11%) was found to be significantly higher than in patients who were not treated with it (16.88%) (p:0.033). There was no significant difference in viral load levels (p:0.513). Furthermore, it was determined that anti-cytokine treatment significantly decreased mortality (p: 0.003) and that there was no significant relationship between CMV reactivation and mortality (p: 0.399). Even though CMV reactivation was high in critical COVID-19 patients who received anti-cytokine treatment, positive developments in morbidity and mortality were observed with early diagnosis and effective treatment.
- Being tested
- CMV DNA analysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV DNA analysisDiagnostic test
CMV DNA quantitative viral load levels were studied
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 cases with anticytokine therapy | Considering the use of anti-cytokines in these patients, it was found that 53 received tocilizumab, 27 received anakinra, and 10 received both. CMV DNA was positive in 38 (22.7%) of the patients included in the study. CMV positivity was found to be significantly higher in 90 patients (31.11%) compared to 77 patients (16.88%) who did not receive anti-cytokine treatment (p:0.033) Receives: Diagnostic Test: CMV DNA analysis | |
| COVID-19 cases without anticytokine therapy | MV positivity was found to be significantly higher in 90 patients (31.11%) compared to 77 patients (16.88%) who did not receive anti-cytokine treatment (p:0.033) Receives: Diagnostic Test: CMV DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between CMV reactivation and anti-cytokine treatment
CMV positivity was found to be significantly higher in who receive anti-cytokine treatment
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start15 Mar 2020
- Primary completion31 Dec 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, MortalityStudies 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
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramazan Gozukucuk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ramazan Gozukucuk, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419206
- Sponsor's protocol ID
- HisarIH-101
- Acronym
- Cytomegalovir
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: published data
Publications
Gozukucuk R, Kilic HH. The relationship between CMV reactivation, anti-cytokine treatment and mortality in critical COVID-19 patients. Pak J Med Sci. 2023 Sep-Oct;39(5):1286-1290. doi: 10.12669/pjms.39.5.7301.
PubMed 37680795
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Infectious Disease and Clinical Microbiology
- ClinicalTrials.gov ID
- NCT05419206
- Acronym / sponsor ID
- Cytomegalovir / HisarIH-101
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Ramazan GozukucukUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 15 Jun 2022 (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.
The risk of secondary infection is high in critical patients hospitalized with the diagnosis of COVID-19. Immunosuppressive treatments are commonly used in critical COVID-19 patients, and immune dysfunction and CMV reactivation can be unnoticed in these patients.
Detailed description
The records of critical patients were reviewed retrospectively. Whether these patients used tocilizumab and/or anakinra and their relationship with CMV reactivation were examined. Furthermore, the relationship between CMV reactivation and mortality and anti-cytokine treatment in patients was also examined. A total of 167 critical COVID-19 patients were included in the study, of which 38 (22.7%) were found to be CMV DNA positive. CMV positivity in patients treated with anti-cytokines (31.11%) was found to be significantly higher than in patients who were not treated with it (16.88%) (p:0.033). There was no significant difference in viral load levels (p:0.513). Furthermore, it was determined that anti-cytokine treatment significantly decreased mortality (p: 0.003) and that there was no significant relationship between CMV reactivation and mortality (p: 0.399). Even though CMV reactivation was high in critical COVID-19 patients who received anti-cytokine treatment, positive developments in morbidity and mortality were observed with early diagnosis and effective treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 cases with anticytokine therapy | – | Diagnostic Test: CMV DNA analysisConsidering the use of anti-cytokines in these patients, it was found that 53 received tocilizumab, 27 received anakinra, and 10 received both. CMV DNA was positive in 38 (22.7%) of the patients included in the study. CMV positivity was found to be significantly higher in 90 patients (31.11%) compared to 77 patients (16.88%) who did not receive anti-cytokine treatment (p:0.033) |
| COVID-19 cases without anticytokine therapy | – | Diagnostic Test: CMV DNA analysisMV positivity was found to be significantly higher in 90 patients (31.11%) compared to 77 patients (16.88%) who did not receive anti-cytokine treatment (p:0.033) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The mean age of the patients was 59.2 (26-91 years), 63.7 years for women, and 58.6 years for men. The study included 167 critical and/or intensive care patients, 24 of whom were female (14%), and 143 of whom were men.
Key inclusion criteria (1 listed)
- Critically ill patients over the age of 18 diagnosed with COVID-19 and patients followed in the intensive care unit.
Key exclusion criteria (3 listed)
- Patients under the age of 18 with a mild/moderate course of COVID-19,
- CMV PCR positive before anti-cytokine treatment,
- patients who underwent hematopoietic stem cell transplantation
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 |
|---|---|---|
| CMV DNA analysisCMV DNA quantitative viral load levels were studied | Diagnostic test | COVID-19 cases with anticytokine therapy, COVID-19 cases without anticytokine therapy |
Primary outcome
The relationship between CMV reactivation and anti-cytokine treatment
Time frame: 2020-2021
CMV positivity was found to be significantly higher in who receive anti-cytokine treatment
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 15 Jun 2022.
- Derived from this study: PubMed 37680795Gozukucuk R, Kilic HH. The relationship between CMV reactivation, anti-cytokine treatment and mortality in critical COVID-19 patients. Pak J Med Sci. 2023 Sep-Oct;39(5):1286-1290. doi: 10.12669/pjms.39.5.7301.
- Individual participant dataSharing planned: Undecided. published data
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.
The record lists no contact. Use the official record to reach the sponsor.
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, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality, run by Ramazan Gozukucuk at 1 site in Turkey (Türkiye).
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 3 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 15 Jun 2022. 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 Turkey (Türkiye). 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?
The relationship between CMV reactivation and anti-cytokine treatment (time frame: 2020-2021). 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 NCT05419206, which also lists 1 linked publication.
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 15 Jun 2022.