Effects of baricitinib on respiratory function in patients treated with corticosteroids for SARS-CoV-2 pneumonia: an observational cohort study (BARI-COVID19)

Study type

• Study topic:
  Human medicinal product

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

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Baricitinib
• Medical condition to be studied:
  COVID-19 pneumonia

Population studied

• Short description of the study population:
  Patients older than 18 years admitted to the hospital because of SARS-CoV-2 pneumonia who have an arterial oxygen partial pressure/fractional inspired oxygen (PaO2/FiO2) ratio less than 200 mmHg on ward (moderate to severe SARS-CoV-2 pneumonia).; All patients admitted during observation period with SARS-CoV-2 pneumonia and respiratory insufficiency (SpO2 ≤ 92% breathing room air) are considered for the; study. Patients older than 80 years or discarded for ICU will be transferred to a geriatric hospital admission whenever there are beds available. Patients are excluded if they have major comorbidities (chronic heart failure, chronic obstructive pulmonary disease on oxygen therapy, obstructive sleep apnea syndrome with continuous positive airway pressure, advanced chronic kidney disease, active malignancies). Patients will be also excluded if they have previously been treated with other immunomodulators (IVIG, INF, anakinra, tocilizumab). Patients admitted to ICU or who died will be considered nonevaluable and thus excluded.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Special population of interest:
  Other
• Special population of interest, other:
  COVID-19 pneumonia patients
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To determine whether the JAK inhibitor baricitinib could offer a beneficial or additive effect to corticosteroids on respiratory function in patients with moderate to severe ARDS due to SARS-CoV-2 pneumonia.
• Outcomes:
  The primary endpoint is defined as the change in SpO2/FiO2 from hospitalization to discharge. Secondary endpoints include the proportion of patients requiring supplemental oxygen at discharge and one month later.
• Data analysis plan:
  We will adjust the analysis of outcome variables using the inverse propensity score weighting (IPSW), which is based on propensity score, to construct a weighted cohort of patients who differed with respect to treatment received but were similar regarding other measured characteristics. To calculate the IPSW will be use a logistic-regression model.