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

NCT04979091 | Completed

• 1 other identifier: HAM-SEX-C19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Critical Illness

Keywords

ICU, COVID-19, testosteron, estradiol, sex-hormone

Outcome Measures

Primary Outcomes (5)

• Sex hormone in critical ill COVID-19 patients

  testosterone

  Day at admission

• Sex hormone in critical ill COVID-19 patients

  estradiol

  Day at admission

• Sex hormone in critical ill COVID-19 patients

  sex hormone-binding globulin

  Day at admission

• Sex hormone in critical ill patients

  testosterone

  Day at admission

• Sex hormone in critical ill patients

  estradiol

  Day at admission

Interventions

Sex Hormones DIAGNOSTIC_TEST

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill Covid-19 patients and Critically ill Non-Covid-19 patients

You may qualify if:

• Admission on ICU
• Covid-19

You may not qualify if:

• \- none

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Federal Ministry of Health, Germany: collaborator

Study Sites (1)

University Medical Center

Hamburg, 20246, Germany

Location

Related Links

• Preprint

MeSH Terms

Conditions

COVID-19; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Kluge, Prof.

  University Medical Center Hamburg-Eppendorf, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 27, 2021
• Study Start: March 8, 2020
• Primary Completion: February 26, 2021
• Study Completion: May 31, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)