Sex Hormone Dysregulations Are Associated With Critical Illness in COVID-19 Patients

NCT ID: NCT04979091

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-08

Study Completion Date

2021-05-31

Brief Summary

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Males develop more severe SARS-CoV-2 infection related disease outcome than females. Herein, sex hormones were repeatedly proposed to play an important role in Covid-19 pathophysiology and immunity. However, it is yet unclear whether sex hormones are associated with Covid-19 outcome in males and females. In this study, we analyzed sex hormones, cytokine and chemokine responses as well as performed a large profile analysis of 600 metabolites in critically-ill male and female Covid-19 patients in comparison to healthy controls and patients with coronary heart diseases as a prime Covid-19 comorbidity. We here show that dysregulated sex hormones, IFN-γ levels and unique metabolic signatures are associated with critical illness in Covid-19 patients. Both, male and female Covid-19 patients, present elevated estradiol levels which positively correlates with IFN-γ levels.

Male Covid-19 patients additionally display severe testosterone and triglyceride deficiencies as compared to female patients and healthy controls. Our results suggest that male Covid-19 patients suffer from multiple metabolic disorders, which may lead to higher risk for fatal outcome. These findings will help to understand molecular pathways involved in Covid-19 pathophysiology.

Detailed Description

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Conditions

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Covid19 Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Sex Hormones

A panel of 13 hormones was measured in plasma samples of COVID-19 patients (total testosterone, free testosterone, dihydrotestosterone, androstenedione, 17-β-estradiol, estrone, sex hormone-binding globulin, thyroid-stimulating hormone, free triiodothyronine (T3), free thyroxine (T4), luteinizing hormone, follicle-stimulating hormone and cortisol).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Admission on ICU
* Covid-19

Exclusion Criteria

\- none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Ministry of Health, Germany

OTHER_GOV

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Kluge, Prof.

Role: STUDY_CHAIR

University Medical Center Hamburg-Eppendorf, Germany

Locations

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University Medical Center

Hamburg, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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HAM-SEX-C19

Identifier Type: -

Identifier Source: org_study_id

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