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

COVID Clinical Trial

— COVISPERM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460534
• Other study ID #: 2020-A01206-33
• Status: Completed
• Phase: N/A
• Start date: May 7, 2020
• Est. completion date: May 12, 2021

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID

Intervention

Diagnostic Test:
• diagnostic
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.

Locations

Country	Name	City	State
France	Hôpital Privé de Parly II	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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