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Completed

NCT Number: NCT04979091

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Admission on ICU
  • Covid-19

Exclusion criteria

  • none

Treatment and study plan

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).

Primary outcomes

  1. Sex hormone in critical ill COVID-19 patients

    Time frame: Day at admission

    testosterone

  2. Sex hormone in critical ill COVID-19 patients

    Time frame: Day at admission

    estradiol

  3. Sex hormone in critical ill COVID-19 patients

    Time frame: Day at admission

    sex hormone-binding globulin

  4. Sex hormone in critical ill patients

    Time frame: Day at admission

    testosterone

  5. Sex hormone in critical ill patients

    Time frame: Day at admission

    estradiol

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Federal Ministry of Health, Germany

Registry information

Official study title

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

Acronym: HAM-SEX-C19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2021
Registry last updated
Aug 6, 2021

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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