Clinical trial NCT04319172: Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients
Official title: Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplant Recipient
Infections, Coronavirus
Keywords: Transplant Recipient
COVID-19
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Spanish Network for Research in Infectious Diseases
name: Grupo de Estudio de la Infección en el Trasplante (GESITRA)
First posted: 2020-03-24
Enrollment: 488
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 16 years with a solid organ transplant diagnosed of COVID-19.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of coronavirus infection in Solid Organ Transplant Recipients
timeFrame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
measure: Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients
timeFrame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
measure: Presence of other risk factors
timeFrame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
measure: Establish the frequency and type of complications related to the net state of the patient immunosuppression
timeFrame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
Secondary outcomes:
measure: Frequency of co-infections
timeFrame: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
measure: Mortality
timeFrame: From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up
measure: Laboratory characteristics
timeFrame: At inclusion and at 28 days of follow up
measure: Determination of coronavirus viral load
timeFrame: At inclusion at 14 days and at 28 days
measure: Microbiological testing
timeFrame: At inclusion at 14 days and at 28 days
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
affiliation: University Hospital Virgen del Rocío
name: Elisa Cordero-Matía, MD-PhD
role: STUDY_CHAIR
References:
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