Observational study to evaluate the potential effects of biological, biosimilar, and targeted synthetic disease-modifying antirheumatic drugs in the appearance of symptoms compatible with COVID-19 infection (PreCOVIDMar)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34824
• EU PAS number:
  EUPAS34806
• Study ID:
  34824
• Official title and acronym:
  Observational study to evaluate the potential effects of biological, biosimilar, and targeted synthetic disease-modifying antirheumatic drugs in the appearance of symptoms compatible with COVID-19 infection (PreCOVIDMar)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This is an observational, retrospective study to determine the cumulative incidence of symptoms compatible with COVID19 infection in patients receiving biological, biosimilar or targeted synthetic disease-modifying antirheumatic drugs (bDMARDs, bsDMARDs, tsDMARDs), when compared with patients suffering from other rheumatic diseases not treated with these drugs. The study also aims to investigate whether there is any immunosuppressive/ immunomodulatory treatment that has a protective effect against symptoms compatible with coronavirus infection.All patients diagnosed with any immune-mediated inflammatory disease (IMID) and actually receiving bDMARDs, bsDMARDs or tsDMARD managed as outpatients in the hospital pharmacy department will be recruited from 14 selected primary care centers in Barcelona (Spain). Additionally, patients attending from September 2019 to March 2020 the Hospital del Mar Rheumatology Department (Barcelona, Spain) and not being treated with these immunomodulatory drugs will also be included. A medical history revision of included patients will be performed, focusing mainly on patient’s comorbidities, current treatments followed and COVID signs and symptoms. Regarding the COVID infection, the following variables were recorded: COVID diagnostic test result, hospitalization due to COVID infection, and presence of COVID symptoms. Last variable was defined as any physical or telephonic contact informing about symptoms compatible with COVID-19 infection, both to the hospital or to the primary care center, from the 1st to the 29th of March.Poisson regression models with robust variance estimation will be used to estimate incidence rate ratios (IRR) and 95% confidence intervals. Models will be adjusted by sex, age and comorbidities.
• Study status:
  Ongoing

Research institution and networks

Institutions

Parc de Salut Mar Barcelona (PSMAR)

Spain

Study timelines

Date when funding contract was signed

Planned: 16/04/2020

Actual: 16/04/2020

Study start date

Planned: 20/04/2020

Actual: 16/04/2020

Date of final study report

Planned: 01/05/2020

Sources of funding

Other

More details on funding

IMIM

Study protocol

Initial protocol

CLINICAL RESEARCH PROTOCOL_PreCOVIDMAR_Eng

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable