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OpenTrials
Completed

NCT Number: NCT05419206

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

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.

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Key information

Conditions

COVID-19, Cytomegalovirus (CMV), Tocilizumab, Anakinra, Mortality COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hisar Hospital Intercontinental

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMV DNA analysis

Diagnostic Test

CMV DNA quantitative viral load levels were studied

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ramazan Gozukucuk

Other

Registry information

Official study title

Department of Infectious Disease and Clinical Microbiology

Acronym: Cytomegalovir

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 15, 2022
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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