Official Title
Long-term Sequelae of Severe Sars-CoV-2 Infections
Brief Summary

By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients withpneumonia 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 therapyis available. Severe courses of the infection not only affect the lungs, but also otherorgans like the heart, kidney, or liver. The lack of preexisting immunity might at leastpartially explain the affection of extra pulmonary organs not yet seen in infections dueto other respiratory viruses. In this observational investigation the study group willfollow up on patients that have been hospitalized due to a SARS-CoV-2 infection, andmonitor 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.

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.

Recruiting
Lung Diseases
Cardiac Disease
Inflammatory Reaction
Eligibility Criteria

Inclusion Criteria:

- hospitalization due to Sars-CoV-2 infection

Exclusion Criteria:

- under 18 years of age

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

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
Giessen, Germany

Investigator: Ulrich Matt, MD, PhD
Contact: 0049064198558773
ulrich.matt@innere.med.uni-giessen.de

Contacts

Ulrich Matt, MD, PhD
0049-(0)641-985-58773
ulrich.matt@innere.med.uni-giessen.de

University of Giessen
NCT Number
MeSH Terms
COVID-19
Lung Diseases
Heart Diseases
Inflammation