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Completed

NCT Number: NCT04319172

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

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.

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Key information

Conditions

Transplant Recipient COVID-19 Coronaviridae Infections Coronavirus Infections Infections Infections, Coronavirus Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of coronavirus infection in Solid Organ Transplant Recipients

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Frequency of co-infections

    Time frame: 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

    Time frame: 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

    Time frame: At inclusion and at 28 days of follow up

    Biochemical analysis, hemogram,

  4. Determination of coronavirus viral load

    Time frame: At inclusion at 14 days and at 28 days

    Nasopharyngeal swabs

  5. Microbiological testing

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Grupo de Estudio de la Infección en el Trasplante (GESITRA)
  • Spanish Network for Research in Infectious Diseases

Registry information

Acronym: COVIDSOT

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 24, 2020
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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