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COVID-19 Detection Tests in Different Body Fluids

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04473352
Recruitment Status : Unknown
Verified August 2020 by Ricardo Reges Maia de Oliveira, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara.
Recruitment status was:  Not yet recruiting
First Posted : July 16, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Universidade Federal do Ceará
Information provided by (Responsible Party):
Ricardo Reges Maia de Oliveira, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara

Study Description
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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.

Condition or disease
Covid19

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
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Diagnostic Accuracy of COVID-19 Detection Tests in Different Body Fluids of Infected Men and Concordance With Viral Cultures
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of Covid19 Detection [ Time Frame: September 2021 ]
    Numerical variables will be described by measurements of central tendency (mean or median) and the respective dispersion measurements. Categorical variables will be described by their absolute values, percentages, or proportions. To compare the differences of continuous variables, we will use the Student t-test or the Mann-Whitney test. For comparison of categorical data, we will use the chi-square test. Univariable and multivariable analyses will be performed to identify predictors of COVID-19 detection.


Biospecimen Retention:   Samples With DNA
Semen, urine, and saliva: Semen samples will be obtained by the patient through masturbation, and collected in sterile containers. Urine samples will be collected from the medium stream at least 4 hours without emptying the bladder. Saliva samples will be obtained by the swab. The first sample will be collected in the first 14 days after the onset of symptoms and the others on a monthly basis. After 2 consecutive negative samples, no more samples will be taken. Only the virus will be researched using qRT-PCR. Peripheral blood: Samples of peripheral blood are collected through peripheral venipuncture. These samples will be collected at the time of inclusion in the study to assess the viral load, and 45 days after the onset of symptoms to determine the serum levels of sex hormones.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult male patients with suspected acute viral status for COVID 19 of the city of Fortaleza, Ceara, Brazil, who agreed to participate in the study.
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
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): NCT04473352


Contacts
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Contact: Ricardo Reges, PhD +55 85 996479789 ricardoreges@me.com
Contact: Eduardo P Miranda, PhD +55 85 991960998 mirandaedp@gmail.com

Sponsors and Collaborators
Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
Universidade Federal do Ceará
Investigators
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Principal Investigator: Ricardo Reges, PhD Nucleo de Pesquisa e Desenvolvimento de Medicamentos
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Ricardo Reges Maia de Oliveira, PhD, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara
ClinicalTrials.gov Identifier: NCT04473352    
Other Study ID Numbers: COVID Fluids
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
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 Ricardo Reges Maia de Oliveira, Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara:
Covid
Body Fluids
Viral Cultures
Detection Tests
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases