Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04446169 |
| Other study ID # |
17104_oss/2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 27, 2020 |
| Est. completion date |
September 2, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
University of Florence |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
