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

March 7, 2024 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

488

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients older than 16 years with a solid organ transplant diagnosed of COVID-19.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus
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
From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up
Laboratory characteristics
Time Frame: At inclusion and at 28 days of follow up
Biochemical analysis, hemogram,
At inclusion and at 28 days of follow up
Determination of coronavirus viral load
Time Frame: At inclusion at 14 days and at 28 days
Nasopharyngeal swabs
At inclusion at 14 days and at 28 days
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
At inclusion at 14 days and at 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

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 Rocio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2020

Primary Completion (Actual)

December 28, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVIDSOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Planning for the study will be shared with potential sites pertaining to Spanish Network for Research in Infectious Disease (REIPI) and Group for the Study of Infection in Transplantation and the Immunocompromised Host (GESITRA-IC) for participation. IPD is not foreseen out of this groups due to the specific characteristics of patients and sites to be candidates for study participation.

IPD Sharing Time Frame

One year after the initiation of the study

IPD Sharing Access Criteria

Spanish Network for Research in Infectious Disease (REIPI) and Group for the Study of Infection in Transplantation and the Immunocompromised Host (GESITRA-IC)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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