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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| female COVID19 patients | Females with COVID19 disease | ||
| male COVID19 patients | Males with COVID19 disease | ||
| female matched COVID19-free patients | Free from disease COVID19 Females matched. | ||
| male matched COVID19-free patients | Free from disease COVID19 males matched. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome and COVID19 severity | Differences in the gut microbiome correlate with severity of disease | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
We will apply the gender framework as defined by the Canadian Institutes for Health Research (CIHR) which includes 4 gender domains: Gender Identity; Gender Roles; Gender Relations; and Institutionalized Gender (https://cihr-irsc.gc.ca/e/50836.html). Such factors include occupation, employment, marital status, number of children, and household responsibilities.
Patients with laboratory confirmed SARS-Cov-2 infection (positive for real-time reverse-transcriptase polymerase-chain reaction assay for pharyngeal swab specimens) of any severity (from asymptomatic to severe manifestations).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Basili, MD | Contact | 0649972018 | stefania.basili@uniroma1.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome - Policlinico Umberto I Roma | Recruiting | Rome | 00166 | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003075 | Coitus |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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serum, plasma, blood cell pellets and faeces
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |