Detection of COVID-19 (SARS-CoV-2) in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)

GCS Ramsay Santé pour l'Enseignement et la Recherche52 enrolled

Overview

The objective of this study is to look for the presence of SARS-CoV-2 in the semen of patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.

This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

COVID

Interventions

diagnosticDIAGNOSTIC_TEST

The principle of this study is to propose to patients in whom a COVID-19 infection is suspected and who are screened for the disease, the joint search for the virus in the semen.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male patient between the ages of 18 and 65 who has read and signed the consent form for participation in the study. * Outpatient or inpatient without signs of respiratory severity, likely to be mobile * Patient whose medical condition warrants screening for COVID-19 by nasopharyngeal swab Exclusion Criteria: * Patient under protective custody, guardianship or trusteeship * Patient not affiliated to the French social security system * Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient

Locations (1)

Hôpital Privé de Parly II

Le Chesnay, France

Outcomes

Primary Outcomes

Testing for the presence of COVID-19 (SARS-CoV-2 virus) in the semen

The search for the SARS-CoV-2 virus in semen will be carried out by RT-PCR analysis with the RealStar kit developed by Altona Diagnostics. The extraction of the nucleic acid suitable for sperm uses the Pure MagNA technique (Diagnostics ROCHE). This is an extraction technique that has already been validated for HIV-type RNA viruses in semen. The biological samples will be analysed either during the study or bio-banked and analysed at the end of the study. Only semen samples from patients detected positive for SARS-CoV-2 by RT-PCR on nasopharyngeal swab will be analyzed.

Time frame: 48 hours

Kinetics of SARS-CoV-2 virus presence in the semen

Patients who have been found to carry the SARS-CoV-2 virus in their semen will be recalled after one month to re-test for the virus. In case of a positive re-test, a new search will be scheduled and so on until a negative result is found.

Time frame: 1 month

Data from ClinicalTrials.gov

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