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Case Series Study to Detect SARS-CoV-2 in Semen of COVID-19 Patients (COVID-19CAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04717011
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Igenomix

Study Description
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Brief Summary:
A descriptive, clinical series, single-centre, national, biomedical study to determine the presence of SARS-CoV-2 in sperm samples from positive PCR patients for COVID-19 and to evaluate the presence of the virus in the sperm samples after a negative PCR for COVID-19

Condition or disease Intervention/treatment
SARS-CoV-2 Diagnostic Test: PCR test

Detailed Description:

In late December 2019, a new coronavirus strain emerged in China causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). Different organizations including the American Society of Reproductive Medicine have recommended a precautionary approach. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended in many countries. The decision to resume the In vitro fertilization (IVF) treatment make us to question if virus could be in gametes affecting couples and reproductive outcomes. The presence of the virus in sperm have contradictory results.

The present study aims to describe if there could be presence of virus in sperm samples of patients with positive diagnosis for COVID-19, and if so, if the virus turns negative on the sperm after the patient recovers and have a negative result for COVID-19. Also it aims to assess the presence of the virus in the seminal plasma and discern if it possible to disseminate it by sexual transmission.

An interim analysis is expected to be carried out once the 50% of the expected recruitment is achieved.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Case Series Biomedical Study to Detect the Presence of SARS-CoV-2 in Semen of Patients Diagnosed With COVID-19 Disease
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: PCR test
    PCR test in two different semen samples from each patient: first with positive diagnosis for COVID-19 and the second after negative diagnosis for COVID-19.

Outcome Measures
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Primary Outcome Measures :
  1. SARS-CoV-2 semen result [ Time Frame: 1 day ]
    PCR results in semen specimen samples with patient COVID-19 positive test


Secondary Outcome Measures :
  1. SARS-CoV-2 semen result [ Time Frame: 2-8 weeks ]
    PCR results in semen specimen samples with patient COVID-19 negative test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include males diagnosed with COVID-19 by positive PCR with ages between 18-65. These patients will be recruited from all participant departments of the hospital and organized by the Quality and/or Occupational Safety department.
Criteria

Inclusion Criteria:

  • Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
  • Male age: 18 - 65 years, both included.
  • COVID-19 positive result by PCR (including symptomatic and asymptomatic subjects).

Exclusion Criteria:

  • Patients with severe symptoms or any other medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and his compliance in the study
  • Known medical history of azoospermia or anejaculation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717011


Contacts
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Contact: Carlos Gomez, BSc, MSc +34963905310 carlos.gomez@igenomix.com

Locations
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Spain
Hospital Ruber Internacional Recruiting
Madrid, Spain, 28034
Contact: Jesus Maria R Franco    +34913875000    jesusm.franco@ruberinternacional.es   
Sponsors and Collaborators
Igenomix
Investigators
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Study Chair: Carlos Simon, MD, PhD Igenomix
Principal Investigator: Nasser Al-Asmar, PhD Igenomix
More Information
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Responsible Party: Igenomix
ClinicalTrials.gov Identifier: NCT04717011    
Other Study ID Numbers: IGX1-COV-NA-20-05
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Igenomix:
SARS-CoV-2
COVID-19
Severe acute respiratory syndrome coronavirus 2
Semen
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases