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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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COVID

Intervention / Treatment
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* Diagnostic Test: diagnostic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COHORT<br>Cohort | Diagnostic Test: diagnostic<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 month |