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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality
• Intervention / Treatment: Diagnostic test: CMV DNA analysis

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 Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Hisar Hospital Intercontinental

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Diagnostic test: CMV DNA analysis; CMV DNA quantitative viral load levels were studied
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)	Diagnostic test: CMV DNA analysis; CMV DNA quantitative viral load levels were studied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relationship between CMV reactivation and anti-cytokine treatment	CMV positivity was found to be significantly higher in who receive anti-cytokine treatment	2020-2021

Collaborators and Investigators

• Sponsor: Ramazan Gozukucuk

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; DNA Virus Infections; Herpesviridae Infections; COVID-19; Cytomegalovirus Infections
• Other Study ID Numbers: HisarIH-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: published data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No