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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Transplant Recipient, Infections, Coronavirus

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of coronavirus infection in Solid Organ Transplant Recipients | Number of Solid Organ Transplant Recipients positive to coronavirus | From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus | 
| Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients | Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients | From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus | 
| Presence of other risk factors | Gathering possible risk factors in coronavirus infection in Solid Organ Transplant | From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus | 
| Establish the frequency and type of complications related to the net state of the patient immunosuppression | Establish the frequency and type of complications related to the net state of the patient immunosuppression | From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of co-infections | Another infections at the time of coronavirus positive infection will be gathered | From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus | 
| Mortality | Number of deaths caused or complicated by coronavirus infection in patients who has recceived Solid Organ Transplant | From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up | 
| Laboratory characteristics | Biochemical analysis, hemogram, | At inclusion and at 28 days of follow up | 
| Determination of coronavirus viral load | Nasopharyngeal swabs | At inclusion at 14 days and at 28 days | 
| Microbiological testing | According to the clinical manifestations at blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia | At inclusion at 14 days and at 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant Recipient, COVID-19