Sex-Informed Data in the COVID-19 Pandemic.

NCT04497402 | Unknown

• 1 other identifier: SAPIENZAGENDERCOVID
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

sex; gender; thrombosis; immunity; gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Gut microbiome and COVID19 severity

  3 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Pregnancy.
• Younger than 18 years of age.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome - Policlinico Umberto I Roma

Rome, 00166, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, blood cell pellets and faeces

MeSH Terms

Conditions

COVID-19; Coitus; Thrombosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sexual Behavior; Behavior; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Stefania Basili, MD

CONTACT

0649972018; stefania.basili@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Internal Medicine

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 4, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 13, 2022

Record last verified: 2021-12

Locations

IT (1)