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

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ClinicalTrials.gov Identifier: NCT04319172
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborators:
Spanish Network for Research in Infectious Diseases
GESITRA-IC
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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
Transplant Recipient Infections, Coronavirus

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentric Study of Coronavirus Disease 2019 (COVID-2019) in Solid Organ Transplant Recipients
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 to study completion ]
    Number of deaths in coronavirus infection in 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


Biospecimen Retention:   Samples Without DNA
  • Biochemical analysis
  • Hemogram
  • Microbiological testing will be made: blood culture, pleural liquid culture, gram stain and culture of sputum, detection of pneumococcus and Legionella pneumophila antigen in urine, in cases of pneumonia.
  • Nasopharyngeal swabs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients older than 16 years with a solid organ transplant diagnosed of COVID-19.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319172


Contacts
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Contact: Elisa Cordero-Matía, MD-PhD +34 670949617 elisacorderom@gmail.com
Contact: Clara Rosso-Fernández, MD-PhD +34 625881764 claram.rosso.sspa@juntadeandalucia.es

Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Spanish Network for Research in Infectious Diseases
GESITRA-IC
Investigators
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Study Chair: Elisa Cordero-Matía, MD-PhD University Hospital Virgen del Rocío
Additional Information:
Publications:

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT04319172    
Other Study ID Numbers: COVIDSOT
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: One year after the initiation of the study
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)

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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:
Transplant Recipient
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases