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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497402
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Stefania Basili, University of Roma La Sapienza

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.


Condition or disease
Covid19

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Sex-Informed Data in the COVID-19 Pandemic.
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : June 1, 2022

Group/Cohort
female COVID19 patients
male COVID19 patients
female matched COVID19-free patients
male matched COVID19-free patients



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Gut microbiome and COVID19 severity [ Time Frame: 3 months ]
    Differences in the gut microbiome correlate with severity of disease


Biospecimen Retention:   Samples With DNA
serum, plasma, blood cell pellets and faeces


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy.
  • Younger than 18 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497402


Contacts
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Contact: Stefania Basili, MD 0649972018 stefania.basili@uniroma1.it

Locations
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Italy
Sapienza University of Rome - Policlinico Umberto I Roma Recruiting
Rome, Italy, 00166
Contact: Stefania Basili, MD    +390649972018    stefania.basili@uniroma1.it   
Principal Investigator: Stefania Basili, MD         
Sub-Investigator: Lucia Stefanini, PhD         
Sub-Investigator: Valeria Raparelli, MD         
Sub-Investigator: Guido Antonelli, MD         
Sub-Investigator: Stefano Corradini, MD         
Sub-Investigator: Roberto Cangemi, MD         
Sub-Investigator: Claudio Mastroianni, MD         
Sub-Investigator: Marcella Visentini, MD         
Sub-Investigator: Maria Ciardi, MD         
Sponsors and Collaborators
University of Roma La Sapienza
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Responsible Party: Stefania Basili, Full Professor of Internal Medicine, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04497402    
Other Study ID Numbers: SAPIENZAGENDERCOVID
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefania Basili, University of Roma La Sapienza:
sex
gender
thrombosis
immunity
gut microbiota