Diagnosis of SARS-CoV2 infection, in different biological materials, in people infected with this virus

  • Funded by Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Total publications:0 publications

Grant number: 20/05623-0

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2021
    2023
  • Funder

    Fundação de Amparo à Pesquisa do Estado de São Paulo [São Paulo Research Foundation] (FAPESP)
  • Principal Investigator

    Maria Cássia Jacintho Mendes Corrêa
  • Research Location

    Brazil
  • Lead Research Institution

    Universidade de São Paulo
  • Research Priority Alignment

    N/A
  • Research Category

    Pathogen: natural history, transmission and diagnostics

  • Research Subcategory

    Pathogen morphology, shedding & natural history

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Not applicable

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Individuals with multimorbidity

  • Occupations of Interest

    Unspecified

Abstract

In general, the diagnosis of SARS-CoV-2 infection worldwide occurs in the acute phase of the disease and through the identification of the virus in samples collected by nasopharyngeal swab and eventually saliva. Little is known about the presence of this agent in other biological materials and at different stages of the disease. Likewise, little is known about the association of the excretion of this agent in these secretions and the immune-humoral response. Clarifying this information could assist in understanding the natural history of the disease and assist in the diagnosis and management of these patients, clarifying important aspects of interpersonal, hospital and community transmission of this agent. Objectives 1 - Investigate the presence of SARS-CoV-2 in a naso pharynx, saliva, urine, blood and feces swab, during the acute and convalescent phase of infection in immunocompetent and immunocompromised patients; 2 - Investigate the presence of SARS-CoV-2 in saliva or naso-pharyngeal swab of contacts of patients with Covid-19; 3 - Correlate the presence of SARS-CoV 2 in these biological materials and the titers of neutralizing antibodies and IgG-type antibodies by ELISA; 4 - Investigate the SARS-CoV-2 permanence and infectivity rate in these patients during the acute and convalescent phase of COVID-19. Methodology - This is an observational, prospective study, to be carried out on patients and asymptomatic contacts of these patients, attended at the Hospital das Clínicas, USP Medical School, Cancer Institute of the State of São Paulo (ICESP) and in the municipality of São Caetano do Sul, diagnosed with SARS-CoV-2 infection. 125 patients will be included, divided into 3 groups of patients: 1 - Symptomatic patients without diagnosis of any previous immunosuppression (50 patients); 2 - Symptomatic patients diagnosed with solid tumors or candidates for Hematopoietic Stem Cell Transplantation (25 patients); 3 - Asymptomatic contacts of these patients (any group - 50 patients). Blood, urine, saliva, and naso pharyngeal and anal swabs will be collected for 5 consecutive weeks, with intervals of one week (days 1, 7, 14, 21, 28) starting up to 72 hours from the time of diagnosis in all patients in groups 1 and 2. For patients in group 3, only saliva and naso pharynx swab will be collected on day 1. For the detection of anti-SARS CoV 2 antibodies, ELISA serological techniques and the neutralization assay will be used. . For viral identification, molecular biology and viral culture techniques will be used. Duplex quantitative assays (internal control and N or E gene) for SARS-CoV-2 will be carried out according to adapted protocols, with the primers and probes for the real-time PCR assay. The viral isolation will be carried out in a security laboratory level 3 (NB-3), and the samples will be subjected to isolation in VeroE6 cells, known to be susceptible to Coronavirus. (AU) and the samples will be subjected to isolation in VeroE6 cells, known to be susceptible to Coronavirus. (AU) and the samples will be subjected to isolation in VeroE6 cells, known to be susceptible to Coronavirus. (AU)