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

NCT04319172 | Completed

• 1 other identifier: COVIDSOT
• Study Type: observational
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant Recipient; Infections, Coronavirus

Keywords

Transplant Recipient; COVID-19

Outcome Measures

Primary Outcomes (4)

• Incidence of coronavirus infection in Solid Organ Transplant Recipients

  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

  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

  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

  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 Outcomes (5)

• 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

• Mortality

  From baseline at the time of signature of informed consent form up to study completion at 3 months folllow-up

• Laboratory characteristics

  At inclusion and at 28 days of follow up

• Determination of coronavirus viral load

  At inclusion at 14 days and at 28 days

• Microbiological testing

  At inclusion at 14 days and at 28 days

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Absence of informed consent after giving the information regarding the study.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Related Publications (10)

• Cordero E, Perez-Romero P, Moreno A, Len O, Montejo M, Vidal E, Martin-Davila P, Farinas MC, Fernandez-Sabe N, Giannella M, Pachon J; Novel influenza A(H1N1) Study Group of Spanish Network for Research in Infectious Diseases (REIPI). Pandemic influenza A(H1N1) virus infection in solid organ transplant recipients: impact of viral and non-viral co-infection. Clin Microbiol Infect. 2012 Jan;18(1):67-73. doi: 10.1111/j.1469-0691.2011.03537.x. Epub 2011 Jul 25.

  PMID: 21790857 BACKGROUND

• Peghin M, Los-Arcos I, Hirsch HH, Codina G, Monforte V, Bravo C, Berastegui C, Jauregui A, Romero L, Cabral E, Ferrer R, Sacanell J, Roman A, Len O, Gavalda J. Community-acquired Respiratory Viruses Are a Risk Factor for Chronic Lung Allograft Dysfunction. Clin Infect Dis. 2019 Sep 13;69(7):1192-1197. doi: 10.1093/cid/ciy1047.

  PMID: 30561555 BACKGROUND

• Eichenberger EM, Soave R, Zappetti D, Small CB, Shore T, van Besien K, Douglass C, Westblade LF, Satlin MJ. Incidence, significance, and persistence of human coronavirus infection in hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2019 Jul;54(7):1058-1066. doi: 10.1038/s41409-018-0386-z. Epub 2018 Nov 1.

  PMID: 30385869 BACKGROUND

• Pinana JL, Madrid S, Perez A, Hernandez-Boluda JC, Gimenez E, Terol MJ, Calabuig M, Navarro D, Solano C. Epidemiologic and Clinical Characteristics of Coronavirus and Bocavirus Respiratory Infections after Allogeneic Stem Cell Transplantation: A Prospective Single-Center Study. Biol Blood Marrow Transplant. 2018 Mar;24(3):563-570. doi: 10.1016/j.bbmt.2017.11.001. Epub 2017 Nov 15.

  PMID: 29155041 BACKGROUND

• Garbino J, Crespo S, Aubert JD, Rochat T, Ninet B, Deffernez C, Wunderli W, Pache JC, Soccal PM, Kaiser L. A prospective hospital-based study of the clinical impact of non-severe acute respiratory syndrome (Non-SARS)-related human coronavirus infection. Clin Infect Dis. 2006 Oct 15;43(8):1009-15. doi: 10.1086/507898. Epub 2006 Sep 13.

  PMID: 16983613 BACKGROUND

• Cordero E, Aydillo T, Farinas MC, Pano-Pardo JR, Pachon J, Viasus D, Riera M, Lopez-Medrano F, Payeras A, Moreno A, Rodriguez-Bano J, Oteo JA, Martinez-Montauti J, Torre-Cisneros J, Segura F, Carratala J; Novel Influenza A(H1N1) Study Group of the SpanishNetwork for Research in Infectious Diseases (REIPI). Immunosuppressed patients with pandemic influenza A 2009 (H1N1) virus infection. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):547-56. doi: 10.1007/s10096-011-1346-3. Epub 2011 Jul 27.

  PMID: 21792558 BACKGROUND

• Tian S, Hu N, Lou J, Chen K, Kang X, Xiang Z, Chen H, Wang D, Liu N, Liu D, Chen G, Zhang Y, Li D, Li J, Lian H, Niu S, Zhang L, Zhang J. Characteristics of COVID-19 infection in Beijing. J Infect. 2020 Apr;80(4):401-406. doi: 10.1016/j.jinf.2020.02.018. Epub 2020 Feb 27.

  PMID: 32112886 BACKGROUND

• Teicher E, Vincent I, Bonhomme-Faivre L, Abbara C, Barrail A, Boissonnas A, Duclos-Vallee JC, Taburet AM, Samuel D, Vittecoq D. Effect of highly active antiretroviral therapy on tacrolimus pharmacokinetics in hepatitis C virus and HIV co-infected liver transplant recipients in the ANRS HC-08 study. Clin Pharmacokinet. 2007;46(11):941-52. doi: 10.2165/00003088-200746110-00002.

  PMID: 17922559 BACKGROUND

• Jain AB, Venkataramanan R, Eghtesad B, Marcos A, Ragni M, Shapiro R, Rafail AB, Fung JJ. Effect of coadministered lopinavir and ritonavir (Kaletra) on tacrolimus blood concentration in liver transplantation patients. Liver Transpl. 2003 Sep;9(9):954-60. doi: 10.1053/jlts.2003.50171.

  PMID: 12942457 BACKGROUND

• Sheikh AM, Wolf DC, Lebovics E, Goldberg R, Horowitz HW. Concomitant human immunodeficiency virus protease inhibitor therapy markedly reduces tacrolimus metabolism and increases blood levels. Transplantation. 1999 Jul 27;68(2):307-9. doi: 10.1097/00007890-199907270-00027.

  PMID: 10440408 BACKGROUND

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

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elisa Cordero-Matía, MD-PhD

  University Hospital Virgen del Rocío

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 12, 2020
• Primary Completion: December 28, 2022
• Study Completion: December 31, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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)

Locations

ES (1)