Sequelae of Sars-CoV-2 Infections

December 4, 2023 updated by: University of Giessen

Long-term Sequelae of Severe Sars-CoV-2 Infections

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Giessen, Germany, 35392
        • Recruiting
        • 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
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients that have been hospitalized due to Covid 19

Description

Inclusion Criteria:

  • hospitalization due to Sars-CoV-2 infection

Exclusion Criteria:

  • under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequelae after COVID-19
Time Frame: 12 months, extension if required
Identify organ dysfunction after SARS-CoV-2 infections
12 months, extension if required

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2020

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECOV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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