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

F

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Completed

Conditions

Infections, Coronavirus
Transplant Recipient

Study type

Observational

Funder types

Other

Identifiers

NCT04319172
COVIDSOT

Details and patient eligibility

About

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.

Full description

There will be a clinical follow-up of the patients included in this study to observe possible complications and survival rate. Data collected form this study will be evaluated with a descriptive statistical analysis of the cohort consisting of analysis of the risk factors of COVID-19. Subsequently a multivaried logistic regression analysis will be performed in which the factors selected from the analysis and those clinically relevant.

Enrollment

488 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients older than 16 years with a solid organ transplant diagnosed of COVID-19.

NOTE: A confirmed case of infection, is defined by a clinical syndrome that is compatible to that of an respiratory infection (fever, cough and/or dyspnea) and the presence of a positive microbiological result.

Exclusion criteria

  • Absence of informed consent after giving the information regarding the study.

Trial contacts and locations

1

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Central trial contact

Clara Rosso-Fernández, MD-PhD; Elisa Cordero-Matía, MD-PhD

Data sourced from clinicaltrials.gov

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