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

Covid19 Clinical Trial

— HAM-SEX-C19  

Official title:

Low Testosterone and High Estradiol Are Associated With Disease Severity in Critically Ill COVID-19 Patients - a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979091
• Other study ID #: HAM-SEX-C19
• Status: Completed
• Start date: March 8, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission on ICU

• Covid-19

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Covid19
• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Federal Ministry of Health, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex hormone in critical ill COVID-19 patients	testosterone	Day at admission
Primary	Sex hormone in critical ill COVID-19 patients	estradiol	Day at admission
Primary	Sex hormone in critical ill COVID-19 patients	sex hormone-binding globulin	Day at admission
Primary	Sex hormone in critical ill patients	testosterone	Day at admission
Primary	Sex hormone in critical ill patients	estradiol	Day at admission

External Links

•   Preprint