Sex-Informed Data in the COVID-19 Pandemic.

Covid19 Clinical Trial

— G-COV  

Official title:

Sex-Informed Data in the COVID-19 Pandemic.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497402
• Other study ID #: SAPIENZAGENDERCOVID
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: University of Roma La Sapienza
• Contact: Stefania Basili, MD
• Phone: 0649972018
• Email: stefania.basili[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy.

• Younger than 18 years of age.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
Italy	Sapienza University of Rome - Policlinico Umberto I Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex differences in platelet and immune function and COVID19 severity	Sex differences in biomarkers of platelet and immune function correlate with severity of disease	3 months
Secondary	Gut microbiome and COVID19 severity	Differences in the gut microbiome correlate with severity of disease	3 months