COVID-19 Detection Tests in Different Body Fluids

NCT ID: NCT04473352

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2021-11-30

Brief Summary

A clinical and experimental study will be carried out in which the clinician will investigate the PCR of the virus early in different body fluids (blood, semen, urine, saliva) and monitor its experimental clearance and evaluate in vitro diagnostic tests and inhibitory factors of viral proliferation.

Detailed Description

The World Health Organization (WHO) declared Coronavirus 2019 (COVID-19) as a pandemic on March 11, 2020. Due to the rapid spread of the severe acute respiratory syndrome coronavirus 2 virus (SARS-CoV-2), we are currently facing an unprecedented global situation. One of the main pillars in the control of an epidemic is the performance of large-scale tests providing a quick and accurate diagnosis so that the authorities can take timely action. Therefore, tests for COVID-19 should be prompt, widely available, and implemented outside the hospital environment, to avoid overloading the health system and decreasing the risks of hospital transmission to other patients and health professionals. Although universal testing is a cornerstone for reducing the burden of COVID-19, the accuracy of the commercially available tests for COVID-19 in Brazil remains uncertain. In addition, the natural history of the disease in the different organs and tissues is not unquestionably known, nor because the virus develops better in some tissues and not others. There are still many unanswered questions regarding COVID-19. allow more accurate knowledge of the natural history of the disease in the timeline taking into account the acute and long-term phases. Several families of viruses can affect the male genitourinary system, as is the case of the Zika (ZKV) and Ebola viruses. There are reports that in young patients infected with ZKV, the virus persists in semen for up to 6 months after the symptomatic condition. The other SARS-CoV-1 itself was detected in human testicles associated with an inflammatory process (orchiepididymitis), suggesting the possibility that these viruses could also be detected in the semen. As SARS-CoV-1 was able to overcome the hemato-gestural barrier and induce severe testicular damage in the previous outbreak, it is possible that men infected with COVID-19 may also have testicular damage. Another question that remains unanswered is whether the coronavirus can remain in the body of people considered recovered from Covid-19 for an indefinite period. It is also unknown whether there are molecules in the body fluids capable of inhibiting viral growth. The expected benefits are related to a better understanding of COVID's natural history19 and which body fluids can contribute to understanding the pathophysiology of the disease. It will be possible to identify the best time and the test with the best accuracy to diagnose the disease. It is our intention to identify substances in body fluids with an antiviral effect

Conditions

Covid19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Group

Patients with suspected acute viral status for COVID 19 will be invited to participate in the identification of the first symptoms. The diagnosis of COVID-19 will be confirmed according to the determinations of the MS through the reaction of qRT-PCR in the nasopharynx swab. Patients will undergo multiple collections of biological material including blood, saliva, semen, and urine. Each patient will be subjected to serial sample collections. The samples will be processed and analyzed for the presence of viral RNA. Patients with 2 consecutive negative samples did not need to perform subsequent collections.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects over the age of 18 years
• Agreement with the IC

Exclusion Criteria

• History of previous prostate surgery or vasectomy
• Inability to assess participation in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Ceará

UNKNOWN

Sponsor Role: collaborator

Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Reges Maia de Oliveira

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo Reges, PhD

Role: PRINCIPAL_INVESTIGATOR

Nucleo de Pesquisa e Desenvolvimento de Medicamentos

Central Contacts

Ricardo Reges, PhD

Role: CONTACT

ricardoreges@me.com

+55 85 996479789

Eduardo P Miranda, PhD

Role: CONTACT

mirandaedp@gmail.com

+55 85 991960998

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Other Identifiers

COVID Fluids

Identifier Type: -

Identifier Source: org_study_id