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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Diagnostic test: diagnostic

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • Hôpital Privé de Parly II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Lucie DELAROCHE, Pharm D, Hôpital Privé de Parly II

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): May 12, 2021
• Study Completion (Actual): May 12, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A01206-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No