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

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)

Overall Status

Completed

CT.gov ID

NCT04460534

Collaborator

(none)

Enrollment

Location

Arm

12.2

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID	Diagnostic Test: diagnostic	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 7, 2020

Actual Primary Completion Date :

May 12, 2021

Actual Study Completion Date :

May 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COHORT Cohort	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.

Arm

Intervention/Treatment

Experimental: COHORT

Cohort

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Privé de Parly II	Le Chesnay		France	78150

Sponsors and Collaborators

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

Principal Investigator: Lucie DELAROCHE, Pharm D, Hôpital privé de Parly II

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GCS Ramsay Santé pour l'Enseignement et la Recherche

ClinicalTrials.gov Identifier:

NCT04460534

Other Study ID Numbers:

2020-A01206-33

First Posted:

Jul 7, 2020

Last Update Posted:

Aug 17, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 17, 2021