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

Completed

• Conditions: Critical Illness; Covid19

• Registration Number: NCT04979091
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-03-08
• Primary Completion: 2021-02-26
• Study Completion: 2021-05-31
• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-25
• Study First Posted: 2021-07-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Admission on ICU
• Covid-19

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sex hormone in critical ill COVID-19 patients	Day at admission	sex hormone-binding globulin
Sex hormone in critical ill patients	Day at admission	estradiol

Trial Locations

Locations (1)

University Medical Center; 🇩🇪 Hamburg, Germany