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

NCT04717011 | Unknown

• 1 other identifier: IGX1-COV-NA-20-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2; COVID-19; Severe acute respiratory syndrome coronavirus 2; Semen

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 semen result

  PCR results in semen specimen samples with patient COVID-19 positive test

  1 day

Secondary Outcomes (1)

• SARS-CoV-2 semen result

  2-8 weeks

Interventions

PCR test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Igenomix: lead

Study Sites (1)

Hospital Ruber Internacional

Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Carlos Simon, MD, PhD

  Igenomix

  STUDY CHAIR

• Nasser Al-Asmar, PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Gomez, BSc, MSc

CONTACT

+34963905310; carlos.gomez@igenomix.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 20, 2021
• Study Start: February 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)