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

Case Series Biomedical Study to Detect the Presence of SARS-CoV-2 in Semen of Patients Diagnosed With COVID-19 Disease

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

Study Overview

• Status: Unknown
• Conditions: SARS-CoV-2
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Carlos Gomez, BSc, MSc; Phone Number: +34963905310; Email: carlos.gomez@igenomix.com

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Ruber Internacional
    • Contact: Jesus Maria R Franco; Phone Number: +34913875000; Email: jesusm.franco@ruberinternacional.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 semen result	PCR results in semen specimen samples with patient COVID-19 positive test	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 semen result	PCR results in semen specimen samples with patient COVID-19 negative test	2-8 weeks

Collaborators and Investigators

• Sponsor: Igenomix
• Investigators: Principal Investigator: Nasser Al-Asmar, PhD, Igenomix

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (ACTUAL): January 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Severe acute respiratory syndrome coronavirus 2; Semen
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IGX1-COV-NA-20-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No