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

Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)
Overall Status
Recruiting
CT.gov ID
NCT04319172
Collaborator
Spanish Network for Research in Infectious Diseases (Other), Grupo de Estudio de la Infección en el Trasplante (GESITRA) (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients
    Actual Study Start Date :
    Mar 12, 2020
    Anticipated Primary Completion Date :
    Jun 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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 Outcome Measures

    1. 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

    2. 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

    3. Laboratory characteristics [At inclusion and at 28 days of follow up]

      Biochemical analysis, hemogram,

    4. Determination of coronavirus viral load [At inclusion at 14 days and at 28 days]

      Nasopharyngeal swabs

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Virgen del Rocio Seville Spain 41013

    Sponsors and Collaborators

    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    • Spanish Network for Research in Infectious Diseases
    • Grupo de Estudio de la Infección en el Trasplante (GESITRA)

    Investigators

    • Study Chair: Elisa Cordero-Matía, MD-PhD, University Hospital Virgen del Rocío

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    ClinicalTrials.gov Identifier:
    NCT04319172
    Other Study ID Numbers:
    • COVIDSOT
    First Posted:
    Mar 24, 2020
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2022