The Relationship Between CMV* Reactivation and Anti-cytokine Treatment in Critical COVID-19 Patients

Completed

• Conditions: COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality
• Interventions: Diagnostic Test: CMV DNA analysis

• Registration Number: NCT05419206
• Lead Sponsor: Ramazan Gozukucuk

Brief 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.

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 Timeline

• Study Start: 2020-03-15
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Last Update Submitted: 2022-06-13
• Study First Posted: 2022-06-15
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

• Critically ill patients over the age of 18 diagnosed with COVID-19 and patients followed in the intensive care unit.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 cases without anticytokine therapy	CMV DNA analysis	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)
COVID-19 cases with anticytokine therapy	CMV DNA analysis	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)

Primary Outcome Measures

Name	Time	Method
The relationship between CMV reactivation and anti-cytokine treatment	2020-2021	CMV positivity was found to be significantly higher in who receive anti-cytokine treatment

Trial Locations

Locations (1)

Hisar Hospital Intercontinental; 🇹🇷 Istanbul, Turkey