Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Solid organ transplant
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Renal impaired
Hepatic impaired
Immunocompromised

Estimated number of subjects

50
Study design details

Main study objective

To know the incidence, clinical manifestations and outcome of infections of COVID-19 on Solid Organ Transplant Recipients

Outcomes

1. Incidence of coronavirus infection in Solid Organ Transplant Recipients2. Clinical manifestations of coronavirus infection in Solid Organ Transplant Recipients 3. Presence of other risk factors4. Establish the frequency and type of complications related to the net state of the patientimmunosuppression, 1. Frequency of co-infections2. Mortality3. Laboratory characteristics4. Determination of coronavirus viral load5. Microbiological testing

Data analysis plan

Results obtained during the study will be analyzed using the SPSS statistical software (version 15.0, SPSS Inc, Chicago, Illinois). A descriptive analysis of all data obtained will be performed. In order to detect significant differences between groups, a Chi-square or a Fisher exact test in the case of categorical variables and the t or a Mann-Whitney test for continuous variables will be applied. Furthermore, a linear trend analysis will also be used, in the case of multiple comparisons. In the multivariate analysis all the variable related to un unfavorable outcome in the unvaried analyses and those, that are clinically relevant significant, will be included.