- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497402
Sex-Informed Data in the COVID-19 Pandemic. (G-COV)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stefania Basili, MD
- Phone Number: 0649972018
- Email: stefania.basili@uniroma1.it
Study Locations
-
-
-
Rome, Italy, 00166
- Recruiting
- Sapienza University of Rome - Policlinico Umberto I Roma
-
Principal Investigator:
- Stefania Basili, MD
-
Sub-Investigator:
- Valeria Raparelli, MD
-
Sub-Investigator:
- Roberto Cangemi, MD
-
Contact:
- Stefania Basili, MD
- Phone Number: +390649972018
- Email: stefania.basili@uniroma1.it
-
Sub-Investigator:
- Lucia Stefanini, PHD
-
Sub-Investigator:
- Guido Antonelli, MD
-
Sub-Investigator:
- Stefano Corradini, MD
-
Sub-Investigator:
- Claudio Mastroianni, MD
-
Sub-Investigator:
- Marcella Visentini, MD
-
Sub-Investigator:
- Maria Ciardi, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with laboratory confirmed SARS-Cov-2 infection of any severity.
Exclusion Criteria:
- Pregnancy.
- Younger than 18 years of age.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sex differences in platelet and immune function and COVID19 severity
Time Frame: 3 months
|
Sex differences in biomarkers of platelet and immune function correlate with severity of disease
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut microbiome and COVID19 severity
Time Frame: 3 months
|
Differences in the gut microbiome correlate with severity of disease
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAPIENZAGENDERCOVID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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