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

Completed

• Conditions: Infections, Coronavirus; Transplant Recipient

• Registration Number: NCT04319172
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Primary Completion: 2022-12-28
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocio; 🇪🇸 Seville, Spain