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Transplant RecipientCOVIDSOTNCT04319172

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

An observational study of Transplant Recipient and Infections, Coronavirus, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Transplant Recipient, Infections, Coronavirus
How many people
488 participants
Where
1 siteSpain
Study dates
12 Mar 2020to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

About this study

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.

Read the 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.

Keywords
Transplant Recipient, COVID-19
Medical subject headings
Coronavirus Infections, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of coronavirus infection in Solid Organ Transplant Recipients

    Number of Solid Organ Transplant Recipients positive to coronavirus

    Measured: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

  2. 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

    Measured: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

  3. Presence of other risk factors

    Gathering possible risk factors in coronavirus infection in Solid Organ Transplant

    Measured: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

  4. 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

    Measured: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

Secondary outcomes (5)

  1. Frequency of co-infections

    Another infections at the time of coronavirus positive infection will be gathered

    Measured: From baseline at the time of signature of informed consent form to day 28 after confirmation of positive test to coronavirus

  2. Mortality

    Number of deaths caused or complicated by coronavirus infection in patients who has recceived Solid Organ Transplant

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

  3. Laboratory characteristics

    Biochemical analysis, hemogram,

    Measured: At inclusion and at 28 days of follow up

  4. Determination of coronavirus viral load

    Nasopharyngeal swabs

    Measured: At inclusion at 14 days and at 28 days

  5. 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

    Measured: At inclusion at 14 days and at 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2020
  2. Study start12 Mar 2020
  3. Primary completion28 Dec 2022
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04319172
Sponsor's protocol ID
COVIDSOT
Acronym
COVIDSOT
Status last verified
Mar 2024
First submitted
20 Mar 2020
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 21790857

  • 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.

    PubMed 30561555

  • 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.

    PubMed 30385869

  • 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.

    PubMed 29155041

  • 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.

    PubMed 16983613

  • 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.

    PubMed 21792558

  • 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.

    PubMed 32112886

  • 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.

    PubMed 17922559

  • 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.

    PubMed 12942457

  • 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.

    PubMed 10440408

Questions about this trial

What is this clinical trial studying?

An observational study of Transplant Recipient and Infections, Coronavirus, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04319172, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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