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

Infections, Coronavirus Clinical Trial

— COVIDSOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319172
• Other study ID #: COVIDSOT
• Status: Completed
• Start date: March 12, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: December 31, 2023
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Infections, Coronavirus
• Transplant Recipient

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocio	Seville

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Grupo de Estudio de la Infección en el Trasplante (GESITRA), Spanish Network for Research in Infectious Diseases

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Frequency of co-infections	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
Secondary	Mortality	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
Secondary	Laboratory characteristics	Biochemical analysis, hemogram,	At inclusion and at 28 days of follow up
Secondary	Determination of coronavirus viral load	Nasopharyngeal swabs	At inclusion at 14 days and at 28 days
Secondary	Microbiological testing	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