AOU Careggi
Florence, Tuscany, 50134, Italy
NCT Number: NCT04446169
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.
Looking for future studies?
Notify Me18 year–80 year
Male
Observational
Florence, Tuscany, 50134, Italy
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Search for SARS-CoV 2 RNA in urine through PCR
Search for SARS-CoV 2 RNA in Semen through PCR
Search for Semen Alterations in patients with past SARS-CoV 2 infection
IIEF-5 assessment in patients with past SARS-CoV 2 infection
Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection
IPSS assessment in patients with past SARS-CoV 2 infection
SECRET questionnaire assessment in patients with past SARS-CoV 2 infection
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
Time frame: Enrollment
SARS-CoV 2 RNA PCR in semen
Time frame: Enrollment
SARS-CoV 2 RNA PCR in urine
Time frame: Enrollment
Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present
Time frame: Enrollment
Spermiogram done following WHO guidelines and criteria
Time frame: Enrollment
International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function
Time frame: Enrollment
SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals
Time frame: Enrollment
International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function
Time frame: Enrollment
Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function
University of Florence
Other
COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04444609
ARDS, Human, COVID-19
London, United Kingdom
View Trial DetailsNCT04359693
SARS-CoV 2
Lille, France
View Trial DetailsNCT04797091
Corona Virus Infection, Coronaviridae Infections
Cologne, Germany
View Trial DetailsNCT04392388
SARS-CoV 2
Paris, France
View Trial Details