Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients (COVIDSOT) (COVID-19)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34406
• EU PAS number:
  EUPAS34349
• Study ID:
  34406
• Official title and acronym:
  Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients (COVIDSOT) (COVID-19)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  United Kingdom
• Study description:
  The overall purpose of this project is to better understand the incidence, risk factors, etiology, clinical manifestations and outcome of tCOVID19 in solid organ transplant recipients. The results obtained will allow us to gain insight on the need of antiviral treatment, on the strategy for complications surveillance, on how to adjust the immunosuppressant therapy and on the level of care in which each patient should be treated. In order to attain the objectives previously described we will develop a multicenter prospective study of consecutive cases of COVID-19 among solid organ transplant recipients. Length of viral shedding and immunological response will be also studied. There will be a clinical follow-up of the patients included in this study to observe possible complications and survival rate. For those centers who cannot recover biological samples, only clinical data will be included. Data collected form this study will be evaluated with a descriptive statistical analysis of the cohort consisting of a univaried analysis of the risk factors of COVID-19. Subsequently a multivaried logistic regression analysis will be performed in which the factors selected from the univaried analysis and those clinically relevant.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Hospital Universitario Virgen del Rocío

Networks

REIPI

Study timelines

Date when funding contract was signed

Planned: 13/03/2020

Actual: 13/03/2020

Study start date

Planned: 20/03/2020

Actual: 20/03/2020

Date of final study report

Planned: 13/03/2022

Sources of funding

Other

More details on funding

ISCIII

Regulatory

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