SHIELD. COVID-19 in immunocompromised patients

Grant number: unknown

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Key facts

  • Disease

    COVID-19
  • start year

    -99
  • Known Financial Commitments (USD)

    $0
  • Funder

    University of São Paulo
  • Principal Investigator

    Silvia and Edson Costa and Abdalla
  • Research Location

    Brazil
  • Lead Research Institution

    N/A
  • Research Priority Alignment

    N/A
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Prognostic factors for disease severity

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Unspecified

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)Children (1 year to 12 years)

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

Immunocompromised patients such as transplant recipients, cancer patients and rheumatologic patients are a risk group for developing the disease and can be a source of virus transmission for prolonged periods, exposing the population and evolving with high mortality. Therefore, it is essential that we know the dynamics of SARS-CoV-2 and COVID-19 infection. New sample collection methodologies such as testing using saliva, serology and molecular typing can assess virus lineage and mapping of its transmission. This information is essential to identify potential targets for vaccine and for the treatment of COVID-19. Treatment data are scarce, therefore clinical trials or compassionate use of drugs used to treat COVID-19 in China and Europe are critical for clinical management and reduction of patient mortality in future epidemics. 600 immunodepressed patients will be evaluated (with cancer, transplants and rheumatologic disease), children and adults asymptomatic and with respiratory symptoms followed at the Hospital das Clínicas of the Faculty of Medicine of USP during the SARS-COV2 epidemic. A group of healthy individuals negative for SARS-COV2 by PCR and serology will be used as control for the evaluation of genetic factors that may be associated with infection by SARS-COV2 and with COVID-19. Samples from asymptomatic patients (saliva, nasal swab, oropharynx and feces) to perform PCR for SARS-COV2 and blood samples for serology will be collected before performing transplants, chemotherapy treatment and use of immunosuppression. The same samples will be collected if patients show respiratory symptoms. Blood samples from all patients will be collected for genetic polymorphism analysis to assess the genetic risk of the studied population and blood samples from symptomatic patients will be collected every 48 hours until resolution of symptoms and for characterization of interleukins as well as stool samples, nasal swab of oropharynx and saliva to assess viral load. The lineage, virulence and mapping of SARS-COV2 will be determined through complete genome sequencing using NANOPORE methodology. The pulmonary function of patients will be evaluated before and after lung transplantation and hematopoietic stem cell transplantation. Symptomatic adult patients will be invited to participate in a clinical trial and/or compassionate use of the medication chloroquine and/or medications available and indicated during the epidemic. Demographic and clinical information will be collected from patients who participate in the study through an electronic form in the RED-CAP program. Risk factors for COVID-19, persistence of SARS-COV2 in the samples, clinical evolution including therapeutic response (when applicable), compromised pulmonary function, quality of life and death will be evaluated.