HAM-SEX-C19: Sex Hormone Dysregulations Are Associated With Critical Illness in COVID-19 Patients

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT04979091
• Collaborator: Federal Ministry of Health, Germany (Other)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 14.8
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Critical Illness	Diagnostic Test: Sex Hormones

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Low Testosterone and High Estradiol Are Associated With Disease Severity in Critically Ill COVID-19 Patients - a Retrospective Analysis
• Actual Study Start Date: Mar 8, 2020
• Actual Primary Completion Date: Feb 26, 2021
• Actual Study Completion Date: May 31, 2021

Outcome Measures

Primary Outcome Measures

1. Sex hormone in critical ill COVID-19 patients [Day at admission]

   testosterone

2. Sex hormone in critical ill COVID-19 patients [Day at admission]

   estradiol

3. Sex hormone in critical ill COVID-19 patients [Day at admission]

   sex hormone-binding globulin

4. Sex hormone in critical ill patients [Day at admission]

   testosterone

5. Sex hormone in critical ill patients [Day at admission]

   estradiol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Admission on ICU

• Covid-19

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center	Hamburg		Germany	20246

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf
• Federal Ministry of Health, Germany

Investigators

• Study Chair: Stefan Kluge, Prof., University Medical Center Hamburg-Eppendorf, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Preprint

Publications

None provided.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT04979091
• Other Study ID Numbers: HAM-SEX-C19
• First Posted: Jul 27, 2021
• Last Update Posted: Aug 6, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitätsklinikum Hamburg-Eppendorf: ICU, COVID-19, testosteron, estradiol, sex-hormone
• Additional relevant MeSH terms: COVID-19; Critical Illness; Hormones

Study Results

No Results Posted as of Aug 6, 2021