Sex-Informed Data in the COVID-19 Pandemic. (G-COV)

December 27, 2021 updated by: Stefania Basili, University of Roma La Sapienza

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • 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:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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