Impact of the COVID-19 epidemic on people with an inflammatory disease (COVIMID)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AF) Nucleoside and nucleotide reverse transcriptase inhibitors

  (J05AG) Non-nucleoside reverse transcriptase inhibitors

  (J05AR) Antivirals for treatment of HIV infections, combinations

  (J05AE) Protease inhibitors

  (J05AX) Other antivirals

  (L04AC) Interleukin inhibitors

  (L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors

  (L03AB) Interferons

  (L04AX03) methotrexate

  (L01XC02) rituximab
• Medical condition to be studied:
  Multiple sclerosis

  Neuromyelitis optica spectrum disorder

  Vasculitis

  Rheumatoid arthritis

  Systemic lupus erythematosus

  Crohn's disease

  Spondylitis

  Psoriasis

  Colitis ulcerative

  HIV infection
• Additional medical condition(s):
  Myelitis,Still’s disease,Juvenile idiopathic arthritis Psoriatic arthropathy Juvenile psoriatic arthritis Arthritis enteropathic Cutaneous lupus erythematosus,Systemic scleroderma,Polymyositis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  1078000

Study design details

• Main study objective:
  The main objective of the study was to assess the risk of severe COVID-19 among two distinct IMID populations (IMID patients suffering from systemic or organ-specific inflammatory disorders (sosIMID) treated with IMA and IMID patients suffering from HIV (hivIMID) treated with ART, respectively), compared to the general population (individuals without IMID and not treated with IMA or ART).
• Outcomes:
  Hospital stay in ICU with a specific code of COVID-19 (as principal or related diagnosis) and/or death during a hospital stay with COVID-19 as principal or related diagnosis. A specific ICD-10 code related to COVID-19 infection (U07.1) has been implemented and a specific ICD-10 code for suspicion of COVID-19 is coming. Less severe COVID-19 infections (hospitalization for COVID-19 without ICU stay or death), Death (whatever the place of death), COVID-related deaths occurring during hospitalization with COVID-19, Spacing or discontinuation of IMA and ART dispensation, IMID flare or destabilization (hospital stay with IMID). HIV complications (hospital stay with HIV or complication related to HIV).
• Data analysis plan:
  The percentage of severe COVID-19 infections will be compared between IMID patients treated with IMA on the one hand and the HIV population treated with ART on the other hand, taking into account the matching on sex and age with controls from the general population, and using a logistic regression model with inverse probability of treatment weighting (IPTW) propensity score. One propensity score will be performed for HIV patients treated with ART and other IMIDs treated with IMA, respectively. These models will be repeated for less severe COVID-19 infections, all-cause deaths, and COVID-19-related deaths. Similarly, these models will be repeated to compare the percentage of IMA treatment discontinuation or spacing as well as the percentage of hospitalizations for an IMID flare or HIV complication (respectively). Where possible and relevant, we will compare the effect of the different types of IMA or ART and the effect of co-treatments on these same endpoints.