COVID-19 (SARS-CoV-2) in Urine and Semen

NCT04446169 | Completed

• 1 other identifier: 17104_oss/2020
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models. In human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab. Given the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine. A saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind. The relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.

Conditions

SARS-CoV 2; Sexual Function and Fertility Disorders; Urinary Function Disorders; Urine; Semen

Keywords

SARS-CoV 2; Sexual Function; Fertility; Urine; Semen

Outcome Measures

Primary Outcomes (4)

• SARS-CoV 2 presence in semen

  SARS-CoV 2 RNA PCR in semen

  Enrollment

• SARS-CoV 2 presence in urine

  SARS-CoV 2 RNA PCR in urine

  Enrollment

• Inflammation in Semen

  Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present

  Enrollment

• Semen quantitative and qualitative analysis

  Spermiogram done following WHO guidelines and criteria

  Enrollment

Secondary Outcomes (4)

• Erectile Function

  Enrollment

• Sexual Habits

  Enrollment

• Urinary function

  Enrollment

• Sexual and Ejaculatory Function

  Enrollment

Study Arms (1)

SARS-CoV 2 Patients

Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections

Diagnostic Test: SARS-CoV 2 RNA PCR Urine; Diagnostic Test: SARS-CoV 2 RNA PCR Semen; Diagnostic Test: Semen Qualitative Analysis; Diagnostic Test: IIEF-5 questionnaire; Diagnostic Test: Male Sexual Health Questionnaire (MSHQ); Diagnostic Test: IPSS questionnaire; Diagnostic Test: SECRET questionnaire; Diagnostic Test: Interleukin assessment in semen

Interventions

SARS-CoV 2 RNA PCR Urine DIAGNOSTIC_TEST

Search for SARS-CoV 2 RNA in urine through PCR

SARS-CoV 2 Patients

SARS-CoV 2 RNA PCR Semen DIAGNOSTIC_TEST

Search for SARS-CoV 2 RNA in Semen through PCR

SARS-CoV 2 Patients

Semen Qualitative Analysis DIAGNOSTIC_TEST

Search for Semen Alterations in patients with past SARS-CoV 2 infection

SARS-CoV 2 Patients

IIEF-5 questionnaire DIAGNOSTIC_TEST

IIEF-5 assessment in patients with past SARS-CoV 2 infection

SARS-CoV 2 Patients

Male Sexual Health Questionnaire (MSHQ) DIAGNOSTIC_TEST

Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection

SARS-CoV 2 Patients

IPSS questionnaire DIAGNOSTIC_TEST

IPSS assessment in patients with past SARS-CoV 2 infection

SARS-CoV 2 Patients

SECRET questionnaire DIAGNOSTIC_TEST

SECRET questionnaire assessment in patients with past SARS-CoV 2 infection

SARS-CoV 2 Patients

Interleukin assessment in semen DIAGNOSTIC_TEST

Assessment of Interleukin presence and quantitative analysis in semen, to study if a previous inflammation/infection due to SARS-CoV 2 in testis was present

SARS-CoV 2 Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Semen analysis
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective cohort study on male patients with a documented previous infection for SARS-CoV2, including symptomatic and asymptomatic patients.Patients need to be eligible for the inclusion criteria and to sign the informed consent to be enrolled to the study

You may qualify if:

• Male Sex
• Age\>18 years
• Will to participate to the study
• Documented past infection for SARS-CoV2 (Nasopharyngeal swab positive for SARS-CoV2 RNA)
• Current negative infection for SARS-CoV2 (Two negative Nasopharyngeal swab for SARS-CoV2 RNA, done following WHO guidelines)

You may not qualify if:

• Age more than 80 years old
• Anejaculation
• Patient's will

Sponsors & Collaborators

• University of Florence: lead
• Azienda Ospedaliero-Universitaria Careggi: collaborator

Study Sites (1)

AOU Careggi

Florence, Tuscany, 50134, Italy

Location

MeSH Terms

Interventions

Seeds

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mauro Gacci, MD

  Careggi University Hospital

  PRINCIPAL INVESTIGATOR

• Sergio Serni, Prof

  University of Florence

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 24, 2020
• Study Start: June 27, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 2, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)