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Sex-Informed Data in the COVID-19 Pandemic.

Sex-Informed Data in the COVID-19 Pandemic.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04497402
Acronym
G-COV
Enrollment
88
Registered
2020-08-04
Start date
2020-09-01
Completion date
2022-12-01
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

sex, gender, thrombosis, immunity, gut microbiota

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.

Interventions

None listed

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Pregnancy. * Younger than 18 years of age.

Design outcomes

Primary

MeasureTime frameDescription
Sex differences in platelet and immune function and COVID19 severity3 monthsSex differences in biomarkers of platelet and immune function correlate with severity of disease

Secondary

MeasureTime frameDescription
Gut microbiome and COVID19 severity3 monthsDifferences in the gut microbiome correlate with severity of disease

Countries

Italy

Contacts

Primary ContactStefania Basili, MD
stefania.basili@uniroma1.it0649972018

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026