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Sequelae of Sars-CoV-2 Infections

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ClinicalTrials.gov Identifier: NCT04442789
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Giessen

Brief Summary:
By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.

Condition or disease
Lung Diseases Cardiac Disease Inflammatory Reaction

Detailed Description:
Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 requires hospitalization in a significant amount of patients. The hospitalization rate and disease severity increases in the elderly and patients with comorbidities such as diabetes, arterial hypertension, lung pathologies and obesity (Garg et al.). Patients with severe infections have pneumonia, requiring prolonged invasive ventilation. Sequelae of longer periods of mechanical ventilation and reduction of quality of life after acute respiratory distress syndrome (ARDS) are described (Herridge et al., 2 references). Besides, SARS-CoV-2 can induce - without preexisting immunity - strong inflammatory reactions, which can affect various organs. COVID-19 specific complications like thromboembolic events, neurologic events, myocardial involvement, or liver damage are reported during the acute stage of the infection. The lung is affected even during less severe infections, and ground glass opacities can result in consolidations (Shi et al.). These changes were reported to persist after discharge (Mo et al.). Acute kidney failure occurs in critically ill patients in 20-40% (Richardson et al.), and 40% of patients admitted to the hospital had proteinuria (Cheng et al.). Myocardial damage is reported, and some patients even presented initially with chest tightness and palpitations before having fever or cough (Zheng et al.). Moreover, patients with COVID-19 have a higher risk of thromboembolic events (Klok et al., Llitjos et al). Typically these patients have a prolonged activated partial thromboplastin time (aPTT), and often antiphospholipid antibodies (Bowles et al.). The long-term consequences of the strong inflammatory response affecting various organs are currently unknown. We hypothesize that some patients will have transient or persistent sequelae requiring medical care. The study group will therefore clinically examine patients that were hospitalized due to COVID-19, and monitor pulmonary, and other organ functions for at least one year after symptom onset. The study group will thereby perform lung and cardial examinations, monitor nephrologic parameters and perform radiology. Pneumologic tests will include a lung function test, a spiroergometry, a 6-minute walking test, and a grip-force test. Cardiac examination will include an echocardiography, and an electrocardiogram. In case of of severe pneumonia, or deterioration in lung function, computer tomography of the lungs will be performed. Blood (and urine) tests will include kidney parameters, inflammatory markers, liver values, and coagulation tests. Additional examinations will be done on an individual basis if clinically indicated, e.g. lung biopsies in case of suspected interstitial fibrosis. Additionally patient samples, which were taken for diagnostic purposes (serum, PBMCs, biopsies) will be stored in the biobank of the German center for lung research (DZL). Clinical evaluation and testing will start 2 months after symptom onset and the last visit is scheduled 10 months later. Depending on the results and the needs of the individual patient additional testing will be conducted.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Sequelae of Severe Sars-CoV-2 Infections
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023



Primary Outcome Measures :
  1. Sequelae after COVID-19 [ Time Frame: 12 months, extension if required ]
    Identify organ dysfunction after SARS-CoV-2 infections


Biospecimen Retention:   Samples With DNA
PBMCs


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients that have been hospitalized due to Covid 19
Criteria

Inclusion Criteria:

  • hospitalization due to Sars-CoV-2 infection

Exclusion Criteria:

  • under 18 years of age

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): NCT04442789


Contacts
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Contact: Ulrich Matt, MD, PhD 0049-(0)641-985-58773 ulrich.matt@innere.med.uni-giessen.de
Contact: Khodr Tello, MD khodr.tello@innere.med.uni-giessen.de

Locations
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Germany
Department of Internal Medicine II, Universities of Giessen and Marburg Lung Center (UGMLC), member of the German Center for Lung Research (DZL), Justus-Liebig-University Recruiting
Giessen, Germany, 35392
Contact: Ulrich Matt, MD, PhD    0049064198558773    ulrich.matt@innere.med.uni-giessen.de   
Sponsors and Collaborators
University of Giessen
Publications:

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Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT04442789    
Other Study ID Numbers: SECOV
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Heart Diseases
Inflammation
Respiratory Tract Diseases
Cardiovascular Diseases
Pathologic Processes