Infections, Coronavirus, Transplant Recipient
Conditions
Keywords
Transplant Recipient, 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.
Interventions
None listed
Sponsors
Spanish Network for Research in Infectious Diseases
Grupo de Estudio de la Infección en el Trasplante (GESITRA)
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 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 | Number of Solid Organ Transplant Recipients positive to coronavirus |
| Clinical manifestations of 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 | Number of participants who present clinical symptoms possibly related to coronavirus infection in Solid Organ Transplant Recipients |
| Presence of other risk factors | From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus | Gathering possible risk factors in coronavirus infection in Solid Organ Transplant |
| 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 | Establish the frequency and type of complications related to the net state of the patient immunosuppression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of co-infections | From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus | Another infections at the time of coronavirus positive infection will be gathered |
| Microbiological testing | At inclusion at 14 days and at 28 days | 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 |
| Mortality | From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up | Number of deaths caused or complicated by coronavirus infection in patients who has recceived Solid Organ Transplant |
| Laboratory characteristics | At inclusion and at 28 days of follow up | Biochemical analysis, hemogram, |
| Determination of coronavirus viral load | At inclusion at 14 days and at 28 days | Nasopharyngeal swabs |
Countries
Spain
Outcome results
None listed