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

Not Applicable

Completed

• Conditions: COVID
• Interventions: Diagnostic Test: diagnostic

• Registration Number: NCT04460534
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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

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

Study Timeline

• Study Start: 2020-05-07
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COHORT	diagnostic	Cohort

Primary Outcome Measures

Name	Time	Method
Testing for the presence of COVID-19 (SARS-CoV-2 virus) in the semen	48 hours	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.
Kinetics of SARS-CoV-2 virus presence in the semen	1 month	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.

Trial Locations

Locations (1)

Hôpital Privé de Parly II; 🇫🇷 Le Chesnay, France