Study identification

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

Networks

REIPI

Contact details

Elisa Cordero

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
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