NCT04584593

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

October 12, 2020

Last Update Submit

November 2, 2020

Conditions

Covid19

Keywords

COVID19SARS-CoV InfectionSemen

Outcome Measures

Primary Outcomes (1)

  • 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

    3 month

Secondary Outcomes (1)

  • SARS-CoV-2 location in patient sperm

    3 month

Study Arms (1)

SARV-Cov

OTHER

Men will give semen, saliva, urine and blood specimens

Biological: Sample

Interventions

SampleBIOLOGICAL

Men will give semen, saliva, nasopharyngeal, urine and blood specimens

SARV-Cov

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSemen sample
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

Related Publications (4)

  • 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.

    PMID: 32109013BACKGROUND

  • 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.

    PMID: 29368629BACKGROUND

  • 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.

    PMID: 30593368BACKGROUND

  • 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.

    PMID: 32352491BACKGROUND

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Louis BUJAN, PR

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis BUJAN, PR

CONTACT

05 67 77 10 41bujan.l@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 14, 2020

Study Start

October 2, 2020

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)