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

NCT04460534 | Completed

• 1 other identifier: 2020-A01206-33
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

COHORT

EXPERIMENTAL

Cohort

Diagnostic Test: diagnostic

Interventions

diagnostic DIAGNOSTIC_TEST

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.

COHORT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Semen collection
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé de Parly II

Le Chesnay, 78150, France

Location

MeSH Terms

Interventions

Diagnosis

Study Officials

• Lucie DELAROCHE, Pharm D

  Hôpital privé de Parly II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: May 7, 2020
• Primary Completion: May 12, 2021
• Study Completion: May 12, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)