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      Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study

      research-article
      Author(s): a , b , * , c , d , e , f , f , g , b , h , i , i , j , k , a , d , e , l , m , n , o , p , q , r , a , e , l , s , e , s , t , s , t , e , e , f , u , e , s , v , c , 1 , a , 1 , * , NAPKON study group
      Publication date (Electronic):
      Journal: eClinicalMedicine
      Publisher: The Author(s). Published by Elsevier Ltd.
      Keywords: COVID-19, Post-COVID-Syndrome (PCS), LongCOVID, Post-acute sequelae of SARS-CoV-2 infection (PASC), SARS-CoV-2 infection, Fatigue, Resilience

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          Abstract

          Background

          Post-COVID syndrome (PCS) is an important sequela of COVID-19, characterised by symptom persistence for >3 months, post-acute symptom development, and worsening of pre-existing comorbidities. The causes and public health impact of PCS are still unclear, not least for the lack of efficient means to assess the presence and severity of PCS.

          Methods

          COVIDOM is a population-based cohort study of polymerase chain reaction (PCR) confirmed cases of SARS-CoV-2 infection, recruited through public health authorities in three German regions (Kiel, Berlin, Würzburg) between November 15, 2020 and September 29, 2021. Main inclusion criteria were (i) a PCR confirmed SARS-CoV-2 infection and (ii) a period of at least 6 months between the infection and the visit to the COVIDOM study site. Other inclusion criteria were written informed consent and age ≥18 years. Key exclusion criterion was an acute reinfection with SARS-CoV-2. Study site visits included standardised interviews, in-depth examination, and biomaterial procurement. In sub-cohort Kiel-I, a PCS (severity) score was developed based upon 12 long-term symptom complexes. Two validation sub-cohorts (Würzburg/Berlin, Kiel-II) were used for PCS score replication and identification of clinically meaningful predictors. This study is registered at clinicaltrials.gov (NCT04679584) and at the German Registry for Clinical Studies (DRKS, DRKS00023742).

          Findings

          In Kiel-I ( n = 667, 57% women), 90% of participants had received outpatient treatment for acute COVID-19. Neurological ailments (61·5%), fatigue (57·1%), and sleep disturbance (57·0%) were the most frequent persisting symptoms at 6–12 months after infection. Across sub-cohorts (Würzburg/Berlin, n = 316, 52% women; Kiel-II, n = 459, 56% women), higher PCS scores were associated with lower health-related quality of life (EQ-5D-5L-VAS/-index: r = -0·54/ -0·56, all p < 0·0001). Severe, moderate, and mild/no PCS according to the individual participant's PCS score occurred in 18·8%, 48·2%, and 32·9%, respectively, of the Kiel-I sub-cohort. In both validation sub-cohorts, statistically significant predictors of the PCS score included the intensity of acute phase symptoms and the level of personal resilience.

          Interpretation

          PCS severity can be quantified by an easy-to-use symptom-based score reflecting acute phase disease burden and general psychological predisposition. The PCS score thus holds promise to facilitate the clinical diagnosis of PCS, scientific studies of its natural course, and the development of therapeutic interventions.

          Funding

          The COVIDOM study is funded by the Network University Medicine (NUM) as part of the National Pandemic Cohort Network (NAPKON).

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          Most cited references25

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          Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review

          W. Joost Wiersinga, Andrew Rhodes, Allen Cheng … (2020)
          The coronavirus disease 2019 (COVID-19) pandemic, due to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused a worldwide sudden and substantial increase in hospitalizations for pneumonia with multiorgan disease. This review discusses current evidence regarding the pathophysiology, transmission, diagnosis, and management of COVID-19.
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            6-month consequences of COVID-19 in patients discharged from hospital: a cohort study

            Chaolin Huang, Lixue Huang, Yeming Wang … (2021)
            Background The long-term health consequences of COVID-19 remain largely unclear. The aim of this study was to describe the long-term health consequences of patients with COVID-19 who have been discharged from hospital and investigate the associated risk factors, in particular disease severity. Methods We did an ambidirectional cohort study of patients with confirmed COVID-19 who had been discharged from Jin Yin-tan Hospital (Wuhan, China) between Jan 7, 2020, and May 29, 2020. Patients who died before follow-up, patients for whom follow-up would be difficult because of psychotic disorders, dementia, or re-admission to hospital, those who were unable to move freely due to concomitant osteoarthropathy or immobile before or after discharge due to diseases such as stroke or pulmonary embolism, those who declined to participate, those who could not be contacted, and those living outside of Wuhan or in nursing or welfare homes were all excluded. All patients were interviewed with a series of questionnaires for evaluation of symptoms and health-related quality of life, underwent physical examinations and a 6-min walking test, and received blood tests. A stratified sampling procedure was used to sample patients according to their highest seven-category scale during their hospital stay as 3, 4, and 5–6, to receive pulmonary function test, high resolution CT of the chest, and ultrasonography. Enrolled patients who had participated in the Lopinavir Trial for Suppression of SARS-CoV-2 in China received severe acute respiratory syndrome coronavirus 2 antibody tests. Multivariable adjusted linear or logistic regression models were used to evaluate the association between disease severity and long-term health consequences. Findings In total, 1733 of 2469 discharged patients with COVID-19 were enrolled after 736 were excluded. Patients had a median age of 57·0 (IQR 47·0–65·0) years and 897 (52%) were men. The follow-up study was done from June 16, to Sept 3, 2020, and the median follow-up time after symptom onset was 186·0 (175·0–199·0) days. Fatigue or muscle weakness (63%, 1038 of 1655) and sleep difficulties (26%, 437 of 1655) were the most common symptoms. Anxiety or depression was reported among 23% (367 of 1617) of patients. The proportions of median 6-min walking distance less than the lower limit of the normal range were 24% for those at severity scale 3, 22% for severity scale 4, and 29% for severity scale 5–6. The corresponding proportions of patients with diffusion impairment were 22% for severity scale 3, 29% for scale 4, and 56% for scale 5–6, and median CT scores were 3·0 (IQR 2·0–5·0) for severity scale 3, 4·0 (3·0–5·0) for scale 4, and 5·0 (4·0–6·0) for scale 5–6. After multivariable adjustment, patients showed an odds ratio (OR) 1·61 (95% CI 0·80–3·25) for scale 4 versus scale 3 and 4·60 (1·85–11·48) for scale 5–6 versus scale 3 for diffusion impairment; OR 0·88 (0·66–1·17) for scale 4 versus scale 3 and OR 1·77 (1·05–2·97) for scale 5–6 versus scale 3 for anxiety or depression, and OR 0·74 (0·58–0·96) for scale 4 versus scale 3 and 2·69 (1·46–4·96) for scale 5–6 versus scale 3 for fatigue or muscle weakness. Of 94 patients with blood antibodies tested at follow-up, the seropositivity (96·2% vs 58·5%) and median titres (19·0 vs 10·0) of the neutralising antibodies were significantly lower compared with at the acute phase. 107 of 822 participants without acute kidney injury and with estimated glomerular filtration rate (eGFR) 90 mL/min per 1·73 m2 or more at acute phase had eGFR less than 90 mL/min per 1·73 m2 at follow-up. Interpretation At 6 months after acute infection, COVID-19 survivors were mainly troubled with fatigue or muscle weakness, sleep difficulties, and anxiety or depression. Patients who were more severely ill during their hospital stay had more severe impaired pulmonary diffusion capacities and abnormal chest imaging manifestations, and are the main target population for intervention of long-term recovery. Funding National Natural Science Foundation of China, Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, National Key Research and Development Program of China, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, and Peking Union Medical College Foundation.
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              Post-acute COVID-19 syndrome

              Ani Nalbandian, Kartik Sehgal, Aakriti Gupta … (2021)
              Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the coronavirus disease 2019 (COVID-19) pandemic, which has resulted in global healthcare crises and strained health resources. As the population of patients recovering from COVID-19 grows, it is paramount to establish an understanding of the healthcare issues surrounding them. COVID-19 is now recognized as a multi-organ disease with a broad spectrum of manifestations. Similarly to post-acute viral syndromes described in survivors of other virulent coronavirus epidemics, there are increasing reports of persistent and prolonged effects after acute COVID-19. Patient advocacy groups, many members of which identify themselves as long haulers, have helped contribute to the recognition of post-acute COVID-19, a syndrome characterized by persistent symptoms and/or delayed or long-term complications beyond 4 weeks from the onset of symptoms. Here, we provide a comprehensive review of the current literature on post-acute COVID-19, its pathophysiology and its organ-specific sequelae. Finally, we discuss relevant considerations for the multidisciplinary care of COVID-19 survivors and propose a framework for the identification of those at high risk for post-acute COVID-19 and their coordinated management through dedicated COVID-19 clinics.
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                Author and article information

                Journal
                Journal ID (nlm-ta): eClinicalMedicine
                Journal ID (iso-abbrev): EClinicalMedicine
                Title: eClinicalMedicine
                Publisher: The Author(s). Published by Elsevier Ltd.
                ISSN (Electronic): 2589-5370
                Publication date PMC-release: 18 July 2022
                Publication date (Print): September 2022
                Publication date (Electronic): 18 July 2022
                Volume: 51
                Page: 101549
                Affiliations
                [a ]Internal Medicine Department I, University Medical Center Schleswig-Holstein Campus Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany
                [b ]Airway Research Center North (ARCN), German Center for Lung Research (DZL), Wöhrendamm 80, 22927 Großhansdorf, Germany
                [c ]Institute of Medical Informatics and Statistics, Kiel University, University Medical Center Schleswig-Holstein, Brunswiker Straße 10, 24105 Kiel, Germany
                [d ]Institute of Epidemiology, Kiel University, University Medical Center Schleswig-Holstein, Niemannsweg 11, 24105 Kiel, Germany
                [e ]Institute of Clinical Epidemiology and Biometry, University of Würzburg, Josef-Schneider-Straße 2, 97080 Würzburg, Germany
                [f ]Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, Luisenstr. 57, 10117 Berlin, Germany
                [g ]Institute of Medical Immunology, Charité – Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany
                [h ]LungenClinic Grosshansdorf, Pneumology, Wöhrendamm 80, 22927 Großhansdorf, Germany
                [i ]Neurology Department, University Medical Center Schleswig-Holstein Campus Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany
                [j ]ENT Department, University Medical Center Schleswig-Holstein Campus Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany
                [k ]Internal Medicine Department III, University Medical Center Schleswig-Holstein Campus Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany
                [l ]Department of Neurology, University Hospital Würzburg, Josef-Schneider-Straße 11, 97080 Würzburg, Germany
                [m ]Imland Klinik Rendsburg, Lilienstraße 20-48, 24768 Rendsburg, Germany
                [n ]Department of Infectious Diseases and Respiratory Medicine, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, 10117 Berlin, Germany
                [o ]Medical Department 2, Hematology/ Oncology and Infectious Diseases, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany
                [p ]University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I for Internal Medicine, Kerpener Straße 62, 50937 Cologne, Germany
                [q ]German Center for Infection Research (DZIF), Partner Site Bonn-Cologne, Kerpener Straße 62, 50937 Cologne, Germany
                [r ]Institute for Medical Informatics, University Medical Center Göttingen, Von-Siebold-Straße 3, 37075 Göttingen, Germany
                [s ]Comprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97080 Würzburg, Germany
                [t ]Department of Internal Medicine I, University Hospital Würzburg, Oberdürrbacher Straße 6, 97080 Würzburg, Germany
                [u ]State Institute of Health, Bavarian Health and Food Safety Authority, Eggenreuther Weg 43, 91058 Erlangen, Germany
                [v ]Clinical Trial Center Würzburg (CTC/ZKS), University Hospital Würzburg, Josef-Schneider-Straße 2, 97080 Würzburg, Germany
                Author notes
                [* ]Corresponding authors at: Internal Medicine Department I, University Medical Center Schleswig-Holstein, Campus Kiel, Arnold-Heller-Straße 3, 24103 Kiel, Germany.
                [1]

                These authors contributed equally.

                Article
                Publisher Item ID: S2589-5370(22)00279-6 Publisher ID: 101549
                DOI: 10.1016/j.eclinm.2022.101549
                PMC ID: 9289961
                PubMed ID: 35875815
                SO-VID: 17337a01-92d4-4804-899c-a5d35f45aa64
                Copyright © © 2022 The Author(s)
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 29 March 2022
                Date revision received : 16 June 2022
                Date accepted : 20 June 2022
                Categories
                Subject: Articles

                Keywords: covid-19,post-covid-syndrome (pcs),longcovid, post-acute sequelae of sars-cov-2 infection (pasc),sars-cov-2 infection,fatigue,resilience
                Data availability:
                Keywords: covid-19, post-covid-syndrome (pcs), longcovid, post-acute sequelae of sars-cov-2 infection (pasc), sars-cov-2 infection, fatigue, resilience

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