COVID-19 Detection Tests in Different Body Fluids

NCT04473352 | Unknown

• 1 other identifier: COVID Fluids
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

Covid; Body Fluids; Viral Cultures; Detection Tests

Outcome Measures

Primary Outcomes (1)

• Accuracy of Covid19 Detection

  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.

  September 2021

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara: lead
• Universidade Federal do Ceará: collaborator

Related Publications (16)

• Koh D, Cunningham AC. Counting Coronavirus Disease 2019 (COVID-19) Cases: Case Definitions, Screened Populations and Testing Techniques Matter. Ann Acad Med Singap. 2020 Mar;49(3):161-165.

  PMID: 32301478 BACKGROUND

• Lin C, Xiang J, Yan M, Li H, Huang S, Shen C. Comparison of throat swabs and sputum specimens for viral nucleic acid detection in 52 cases of novel coronavirus (SARS-Cov-2)-infected pneumonia (COVID-19). Clin Chem Lab Med. 2020 Jun 25;58(7):1089-1094. doi: 10.1515/cclm-2020-0187.

  PMID: 32301745 BACKGROUND

• Ling Y, Xu SB, Lin YX, Tian D, Zhu ZQ, Dai FH, Wu F, Song ZG, Huang W, Chen J, Hu BJ, Wang S, Mao EQ, Zhu L, Zhang WH, Lu HZ. Persistence and clearance of viral RNA in 2019 novel coronavirus disease rehabilitation patients. Chin Med J (Engl). 2020 May 5;133(9):1039-1043. doi: 10.1097/CM9.0000000000000774.

  PMID: 32118639 BACKGROUND

• Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med. 2020 Jun 25;58(7):1070-1076. doi: 10.1515/cclm-2020-0285.

  PMID: 32172228 BACKGROUND

• Liu R, Ma Q, Han H, Su H, Liu F, Wu K, Wang W, Zhu C. The value of urine biochemical parameters in the prediction of the severity of coronavirus disease 2019. Clin Chem Lab Med. 2020 Jun 25;58(7):1121-1124. doi: 10.1515/cclm-2020-0220.

  PMID: 32286242 BACKGROUND

• Mardani R, Ahmadi Vasmehjani A, Zali F, Gholami A, Mousavi Nasab SD, Kaghazian H, Kaviani M, Ahmadi N. Laboratory Parameters in Detection of COVID-19 Patients with Positive RT-PCR; a Diagnostic Accuracy Study. Arch Acad Emerg Med. 2020 Apr 4;8(1):e43. eCollection 2020.

  PMID: 32259132 BACKGROUND

• Padoan A, Cosma C, Sciacovelli L, Faggian D, Plebani M. Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics. Clin Chem Lab Med. 2020 Jun 25;58(7):1081-1088. doi: 10.1515/cclm-2020-0443.

  PMID: 32301749 BACKGROUND

• Pan F, Xiao X, Guo J, Song Y, Li H, Patel DP, Spivak AM, Alukal JP, Zhang X, Xiong C, Li PS, Hotaling JM. No evidence of severe acute respiratory syndrome-coronavirus 2 in semen of males recovering from coronavirus disease 2019. Fertil Steril. 2020 Jun;113(6):1135-1139. doi: 10.1016/j.fertnstert.2020.04.024. Epub 2020 Apr 17.

  PMID: 32482249 BACKGROUND

• Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.

  PMID: 32159775 BACKGROUND

• Wolfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Muller MA, Niemeyer D, Jones TC, Vollmar P, Rothe C, Hoelscher M, Bleicker T, Brunink S, Schneider J, Ehmann R, Zwirglmaier K, Drosten C, Wendtner C. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1.

  PMID: 32235945 BACKGROUND

• Wu J, Liu J, Li S, Peng Z, Xiao Z, Wang X, Yan R, Luo J. Detection and analysis of nucleic acid in various biological samples of COVID-19 patients. Travel Med Infect Dis. 2020 Sep-Oct;37:101673. doi: 10.1016/j.tmaid.2020.101673. Epub 2020 Apr 18.

  PMID: 32311437 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Yu F, Yan L, Wang N, Yang S, Wang L, Tang Y, Gao G, Wang S, Ma C, Xie R, Wang F, Tan C, Zhu L, Guo Y, Zhang F. Quantitative Detection and Viral Load Analysis of SARS-CoV-2 in Infected Patients. Clin Infect Dis. 2020 Jul 28;71(15):793-798. doi: 10.1093/cid/ciaa345.

  PMID: 32221523 BACKGROUND

• Castro R, Luz PM, Wakimoto MD, Veloso VG, Grinsztejn B, Perazzo H. COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil. Braz J Infect Dis. 2020 Mar-Apr;24(2):180-187. doi: 10.1016/j.bjid.2020.04.003. Epub 2020 Apr 18.

  PMID: 32330437 RESULT

• Chen Y, Chen L, Deng Q, Zhang G, Wu K, Ni L, Yang Y, Liu B, Wang W, Wei C, Yang J, Ye G, Cheng Z. The presence of SARS-CoV-2 RNA in the feces of COVID-19 patients. J Med Virol. 2020 Jul;92(7):833-840. doi: 10.1002/jmv.25825. Epub 2020 Apr 25.

  PMID: 32243607 RESULT

• Infantino M, Grossi V, Lari B, Bambi R, Perri A, Manneschi M, Terenzi G, Liotti I, Ciotta G, Taddei C, Benucci M, Casprini P, Veneziani F, Fabbri S, Pompetti A, Manfredi M. Diagnostic accuracy of an automated chemiluminescent immunoassay for anti-SARS-CoV-2 IgM and IgG antibodies: an Italian experience. J Med Virol. 2020 Sep;92(9):1671-1675. doi: 10.1002/jmv.25932. Epub 2020 May 10.

  PMID: 32330291 RESULT

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.

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

• Ricardo Reges, PhD

  Nucleo de Pesquisa e Desenvolvimento de Medicamentos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Reges, PhD

CONTACT

+55 85 996479789; ricardoreges@me.com

Eduardo P Miranda, PhD

CONTACT

+55 85 991960998; mirandaedp@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 16, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share