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

COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2; Urine; Sexual Function and Fertility Disorders; Semen; Urinary Function Disorders
• Intervention / Treatment: 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

Detailed Description

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.

According to results obtained, follow up will be tailored to patients (assessment for COVID 19 infections and/or further analysis/folliow-up in case of abnormal findings) 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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • AOU Careggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• 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

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; Search for SARS-CoV 2 RNA in urine through PCR; Diagnostic test: SARS-CoV 2 RNA PCR Semen; Search for SARS-CoV 2 RNA in Semen through PCR; Diagnostic test: Semen Qualitative Analysis; Search for Semen Alterations in patients with past SARS-CoV 2 infection; Diagnostic test: IIEF-5 questionnaire; IIEF-5 assessment in patients with past SARS-CoV 2 infection; Diagnostic test: Male Sexual Health Questionnaire (MSHQ); Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection; Diagnostic test: IPSS questionnaire; IPSS assessment in patients with past SARS-CoV 2 infection; Diagnostic test: SECRET questionnaire; SECRET questionnaire assessment in patients with past SARS-CoV 2 infection; Diagnostic test: Interleukin assessment in semen; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile Function	International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function	Enrollment
Sexual Habits	SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals	Enrollment
Urinary function	International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function	Enrollment
Sexual and Ejaculatory Function	Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function	Enrollment

Collaborators and Investigators

• Sponsor: University of Florence
• Collaborators: Azienda Ospedaliero-Universitaria Careggi
• Investigators: Principal Investigator: Mauro Gacci, MD, Careggi University Hospital; Study Director: Sergio Serni, Prof, University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Urine; Fertility; SARS-CoV 2; Semen; Sexual Function
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 17104_oss/2020

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