Sex-Informed Data in the COVID-19 Pandemic.

• Conditions: Covid19

• Registration Number: NCT04497402
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Sex and gender matter to health equity, especially in a pandemic. Sex (a biological attribute) and gender (a social construct) may influence an individual's susceptibility, vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARS and MERS), male sex was associated with worse outcomes. Both immune and the hemostatic response display ample sexual dimorphism.

The primary aim of the study is to determine whether sex differences in biomarkers of platelet and immune function, gut microbiome, clinical characteristics, therapy, clinical cost sensitive outcomes (i.e. in-hospital transition of care, case severity, and mortality due to COVID-19) exist in patients affected by COVID-19.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-04
• Study Start: 2020-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2022-01-13
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Patients with laboratory confirmed SARS-Cov-2 infection of any severity.

Exclusion Criteria

• Pregnancy.
• Younger than 18 years of age.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sex differences in platelet and immune function and COVID19 severity	3 months	Sex differences in biomarkers of platelet and immune function correlate with severity of disease

Secondary Outcome Measures

Name	Time	Method
Gut microbiome and COVID19 severity	3 months	Differences in the gut microbiome correlate with severity of disease

Trial Locations

Locations (1)

Sapienza University of Rome - Policlinico Umberto I Roma; 🇮🇹 Rome, Italy