Pilot Study to Detect SARS-CoV-2 Virus in Sperm (COVSPERM)
Primary Purpose
Covid19
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sample
Sponsored by
About this trial
This is an interventional other trial for Covid19 focused on measuring COVID19, SARS-CoV Infection, Semen
Eligibility Criteria
Inclusion Criteria:
- Patient aged 18 to 50, male.
- Patient in acute phase of infection with SARS-CoV-2 and whose RT-PCR shows the viral genome in the nasopharyngeal or salivary sample or in any other sample.
- Patient who can come to the laboratory for samples
- Patient having given his free and informed consent and having signed the consent
- Patient affiliated to a social security scheme or equivalent
Exclusion Criteria:
- Patient having previously consulted for male infertility or having previously carried out a semen examination which was abnormal (WHO standard)
- Patient with ejaculation disorder or unable to take a semen sample or with an abnormal semen volume (<1.5 mL).
- Patient who would present serious clinical signs that would not allow him to travel to the investigating center to take samples.
- Patient under a protection regime for adults (including guardianship, curatorship or safeguard of justice.
Sites / Locations
- University Hospital ToulouseRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SARV-Cov
Arm Description
Men will give semen, saliva, urine and blood specimens
Outcomes
Primary Outcome Measures
SARS-CoV-2 genomic RNA in patient sperm
Search for presence of SARS-CoV-2 genomic RNA in patients sperm when they are in the acute phase of the infection with reverse transcriptase polymerase chain reaction
Secondary Outcome Measures
SARS-CoV-2 location in patient sperm
Search of location of SARS-Cov-2 in patient sperm after centrifugation
Full Information
NCT ID
NCT04584593
First Posted
October 12, 2020
Last Updated
November 2, 2020
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04584593
Brief Title
Pilot Study to Detect SARS-CoV-2 Virus in Sperm
Acronym
COVSPERM
Official Title
Pilot Study to Detect SARS-CoV-2 Virus in Sperm : a COVID-19 Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.
Detailed Description
Since the end of 2019, an epidemic of SARS-CoV-2 infections (COVID-19) began in China and is now a global pandemic affecting more than 3 millions of people. Droplets and close contact are the most common routes of transmission of SARS-CoV-2 and aerosol transmission may be another route. Researchers have detected SARS-CoV-2 in samples of respiratory tract, saliva, stool, gastrointestinal tract, urine, tears and conjunctival secretions of COVID-19 patients.
Vertical transmission from mother to infant has been suspected, but not confirmed to date. Information about localization of SARS-CoV-2 in the genital tract or shedding is poorly documented and the results of these studies were discrepant. One of two studies have reported SARS-CoV-2 RNA in semen from six infected patients. However, there is no data on the duration of the seminal excretion of the virus, its viral load and infectiousness and on its localization in semen compartments (cells, seminal plasma, spermatozoa).
The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.
This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID19, SARS-CoV Infection, Semen
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SARV-Cov
Arm Type
Other
Arm Description
Men will give semen, saliva, urine and blood specimens
Intervention Type
Biological
Intervention Name(s)
Sample
Intervention Description
Men will give semen, saliva, nasopharyngeal, urine and blood specimens
Primary Outcome Measure Information:
Title
SARS-CoV-2 genomic RNA in patient sperm
Description
Search for presence of SARS-CoV-2 genomic RNA in patients sperm when they are in the acute phase of the infection with reverse transcriptase polymerase chain reaction
Time Frame
3 month
Secondary Outcome Measure Information:
Title
SARS-CoV-2 location in patient sperm
Description
Search of location of SARS-Cov-2 in patient sperm after centrifugation
Time Frame
3 month
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Semen sample
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 18 to 50, male.
Patient in acute phase of infection with SARS-CoV-2 and whose RT-PCR shows the viral genome in the nasopharyngeal or salivary sample or in any other sample.
Patient who can come to the laboratory for samples
Patient having given his free and informed consent and having signed the consent
Patient affiliated to a social security scheme or equivalent
Exclusion Criteria:
Patient having previously consulted for male infertility or having previously carried out a semen examination which was abnormal (WHO standard)
Patient with ejaculation disorder or unable to take a semen sample or with an abnormal semen volume (<1.5 mL).
Patient who would present serious clinical signs that would not allow him to travel to the investigating center to take samples.
Patient under a protection regime for adults (including guardianship, curatorship or safeguard of justice.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis BUJAN, PR
Phone
05 67 77 10 41
Ext
+33
Email
bujan.l@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis BUJAN, PR
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis BUJAN, Pr
First Name & Middle Initial & Last Name & Degree
Louis BUJAN, PR
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32109013
Citation
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Results Reference
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PubMed Identifier
29368629
Citation
Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Berri M, Gauger PC, Pozzi N, Authie E, Rose N, Grasland B. Evidence of porcine epidemic diarrhea virus (PEDV) shedding in semen from infected specific pathogen-free boars. Vet Res. 2018 Jan 24;49(1):7. doi: 10.1186/s13567-018-0505-2.
Results Reference
background
PubMed Identifier
30593368
Citation
Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Gauger PC, Pozzi N, Berri M, Authie E, Rose N, Grasland B. Limited shedding of an S-InDel strain of porcine epidemic diarrhea virus (PEDV) in semen and questions regarding the infectivity of the detected virus. Vet Microbiol. 2019 Jan;228:20-25. doi: 10.1016/j.vetmic.2018.09.025. Epub 2018 Oct 11.
Results Reference
background
PubMed Identifier
32352491
Citation
Baud D, Greub G, Favre G, Gengler C, Jaton K, Dubruc E, Pomar L. Second-Trimester Miscarriage in a Pregnant Woman With SARS-CoV-2 Infection. JAMA. 2020 Jun 2;323(21):2198-2200. doi: 10.1001/jama.2020.7233.
Results Reference
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Pilot Study to Detect SARS-CoV-2 Virus in Sperm
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