VILA-COVID 19 RETROSPECTIVE OBSERVATIONAL CLINICAL STUDY PROTOCOL: EARLY ADMINISTRATION OF CORTIC THERAPY AND ANTI-INFLAMMATORIES IN PATIENTS WITH COVID 19 DIAGNOSIS. (COVID-19) (VILACOVID 19-CTC)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36151
• EU PAS number:
  EUPAS34934
• Study ID:
  36151
• Official title and acronym:
  VILA-COVID 19 RETROSPECTIVE OBSERVATIONAL CLINICAL STUDY PROTOCOL: EARLY ADMINISTRATION OF CORTIC THERAPY AND ANTI-INFLAMMATORIES IN PATIENTS WITH COVID 19 DIAGNOSIS. (COVID-19) (VILACOVID 19-CTC)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  n the current pandemic situation, standardization criteria are lacking in the use of corticosteroids in patients with ARDS secondary to COVID 19. The objective of our study is to record our experience in the treatment of patients with COVID 19, to assess the results of those who have corticosteroid therapy, anti-inflammatory drugs (colchicine and / or indomethacin), biological therapies (tocilizumab and / or anakinra) and immunoglobulins, quantifying the evolution of the reactants in the acute phase of these patients (PCR, ferritin, Dimero D, IL 6), the PAFI or SAFI (if PAFI not available) and radiological changes of the patient
• Study status:
  Ongoing

Research institutions and networks

Institutions

Hospital de Viladecans-Universidad de Barcelona

Study timelines

Date when funding contract was signed

Planned: 10/04/2020

Actual: 16/03/2020

Study start date

Planned: 13/03/2020

Actual: 16/03/2020

Data analysis start date

Planned: 08/06/2020

Date of interim report, if expected

Planned: 01/08/2020

Date of final study report

Planned: 01/09/2020

Sources of funding

Other

More details on funding

Hospital

Study protocol

Initial protocol

Protocol_villacovid 19

Regulatory

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