SARS-CoV-2 viral load in the respiratory tract and in blood as factor associated to the clinical outcomes in adults with COVID-19 (COVID_CV)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pneumonia

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To analyze the influence of the SARS-CoV-2 viral load in the lower respiratory tract (sputum, or invasive samples if clinically indicated), as well as in blood and feces (indicators of disseminated disease), as factors associated with the evolution of the disease, measured by the need for assisted ventilation and cure or death.
• Outcomes:
  Virologic variables will be included in an analysis together with demographics, co-morbidities, and the clinical and radiological characteristics of the pneumonia. Also, the sensitivity of the SARS-CoV-2 RT-PCR in nasopharyngeal swabs will be evaluated vs. sputum and viremia. Finally, the excretion and infectivity of the virus in feces will be determined after the patients are discharged, - Characterize viral load in: lower respiratory tract/blood/feces in COVID-19 pneumonia. - Analyze the association of viral load/presence of disseminated disease with the progression of pneumonia to respiratory failure and mortality. - Determine the diagnostic sensitivity of nasopharyngeal swabs vs. sputum and the excretion time in stool- Analyze the viability of the excreted virus in feces
• Data analysis plan:
  The inclusion of 400 patients diagnosed with COVID-19, their clinical evaluation and the virologic characterization of the infection in the proposed samples will provide us with information of key importance for the management of these patients. It will provide us with information on the optimal clinical sample to be used for greater sensitivity and specificity in the diagnosis of these patients. In addition, the evaluation of the viral load at each stage of the disease will allow us to stratify the cases based on their prognosis. The analysis of the excretion of the particles and their viability will be key when establishing adequate measures to minimize the transmission of the disease.