LO-COCO: LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions
Study Details
Study Description
Brief Summary
Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of SARS-CoV-2 infection, the purpose of the study is to investigate whether in patients recovered from COVID-19 disease, SARS-CoV-2 infection has induced: 1) endocrine-metabolic function damage; 2) neuro-psychiatric damage; 3) muscle damage; 4) pulmonary damage; 5) cardiological damage; 6) venous vascular damage; 7) dermatological damage. Patients will be evaluated at baseline (at discharge from infectious and/or pneumology unit) and after 3- 12 months. A better definition of the prevalence and type of sequelae after recovery from COVID-19 disease could significantly improve the therapeutic management and long-term follow-up of these patients, with a relevant impact in terms of health resources and public health.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The aim of the study is to investigate whether in patients recovered from COVID-19 disease, SARS-CoV-2 infection has induced: 1) Endocrine-metabolic function damage, 2) Neuro-psychiatric damage, 3) Muscle damage, 4) Pulmonary damage, 5) Cardiological damage, 6) Post-thrombotic vascular damage, 7) Dermatological damage.
The assessment of the potential endocrine-metabolic function damage will comprise the investigation of alterations in particular in: thyrotropic axis (prevalence of hypothyroidism and alterations of the thyroid gland); female gonadotropic axis (prevalence of hypogonadism) with assessment of potentially impaired reproductive and sexual function (prevalence of morpho-structural alterations of the ovary, sexual dysfunction); corticotropic axis (prevalence of hypoadrenalism and alterations of the adrenal gland); somatotropic axis (prevalence of growth hormone deficiency); lactotropic axis (prevalence of hyperprolactinaemia); metabolic profile (prevalence of metabolic syndrome, overweight, obesity, insulin resistance, type 2 diabetes mellitus, dyslipidemia, hypovitaminosis D).
The assessment of the potential neuro-psychiatric damage will comprise the investigation of prevalence of depression, alteration in the quality of life, apathy, anxiety, deficit of attention and cognitive skills.
The assessment of the potential muscle damage will comprise the investigation of prevalence of fatigue, reduced resistance and muscle strength, reduced muscle power, reduced exercise tolerance, myopathy.
The assessment of the potential pulmonary damage will comprise the investigation of prevalence of parenchymal sequelae of interstitial/organized pneumonia, lung dysfunctions, dyspnoea.
The assessment of the potential cardiological damage will comprise the investigation of prevalence of echocardiographic changes at rest and during echocardiogram stress tests, dysfunctions in cardiopulmonary performance.
The assessment of the potential post-thrombotic vascular damage will comprise the investigation of prevalence of previously unknown deep venous thrombosis.
The assessment of the potential dermatological damage will comprise the investigation of prevalence of cutaneous and mucosal lesions, defluvium with identification of specific trichoscopic patterns and onychopathies with identification of specific onychoscopic/capillaroscopic patterns.
Patients will be evaluated at baseline (at discharge from infectious and/or pneumology unit) and after 3-12 months.
Study Design
Outcome Measures
Primary Outcome Measures
- Identification of the most frequent phenotypes of Long-COVID syndrome among for COVID-19 patients recently hospitalized and dismissed [Change from baseline at 3-12 months]
This pilot study will allow identifying the frequency and type of endocrinologic, muscular, cardiovascular, pulmonary, dermatological, metabolic and neuropsychiatric disorders that contribute to the long covid syndrome .
Secondary Outcome Measures
- Thyroid dysfunctions [Change from baseline at 3-12 months]
Prevalence of thyroid dysfunctions (hypo, hyper functions; thyroiditis)
- Female gonadal dysfunctions [Change from baseline at 3-12 months]
Prevalence of female gonadal dysfunctions (hypogonadism and female sexual dysfunctions)
- Adrenal dysfunctions [Change from baseline at 3-12 months]
Prevalence of adrenal dysfunctions (hypocortisolism)
- Pituitary dysfunctions [Change from baseline at 3-12 months]
Prevalence of pituitary dysfunctions (hyperprolactinemia, GH deficiency)
- Metabolic dysfunctions [Change from baseline at 3-12 months]
Prevalence of metabolic dysfunctions (metabolic syndrome, type 2 diabetes, overweight, obesity, insulin-resistance, dyslipidemia, hypovitaminosis D)
- Neuro-psychiatric dysfunctions [Change from baseline at 3-12 months]
Prevalence of depression, alteration of the quality of life, apathy, anxiety, deficit of attentional and cognitive skills
- Muscle dysfunctions [Change from baseline at 3-12 months]
Prevalence of fatigue, reduced resistance and muscle strength, reduced muscle power, reduced exercise tolerance, myopathy.
- Pulmonary dysfunctions [Change from baseline at 3-12 months]
Prevalence of persisting respiratory discomfort in relation to lung function and radiological outcomes (interstitial/organized pneumonia, pulmonary fibrosis)
- Cardiological dysfunctions [Change from baseline at 3-12 months]
Prevalence of echocardiographic changes at rest and during echocardiogram stress tests, dysfunctions in cardiopulmonary performance
- Post-thrombotic vascular dysfunctions [Change from baseline at 3-12 months]
Prevalence of previously unknown deep venous thrombosis
- Dermatological dysfunctions [Change from baseline at 3-12 months]
Prevalence of cutaneous and mucosal lesions, defluvium with identification of specific trichoscopic patterns and onychopathies with identification of specific onychoscopic/capillaroscopic patterns.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients of both sexes recovered from SARS-CoV-2 infection (two negative nasopharyngeal swabs, negative IgM and positive anti SARS-CoV-2 IgG);
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Aged over 18 years of age;
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Ability to understand protocol procedures
Exclusion Criteria:
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Any psychological/psychiatric/other medical conditions compromising the understanding of the nature and purpose of the study, and of its possible consequences
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uncooperative attitude of the patient
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Federico II University of Naples | Naples | Italy | 80131 |
Sponsors and Collaborators
- Federico II University
- Azienda Sanitaria Locale Napoli 2 Nord
Investigators
- Principal Investigator: Annamaria Colao, Prof, Federico II University
Study Documents (Full-Text)
None provided.More Information
Publications
- Agarwal S, Agarwal SK. Endocrine changes in SARS-CoV-2 patients and lessons from SARS-CoV. Postgrad Med J. 2020 Jul;96(1137):412-416. doi: 10.1136/postgradmedj-2020-137934. Epub 2020 Jun 11. Review.
- Auriemma RS, Pirchio R, Liccardi A, Scairati R, Del Vecchio G, Pivonello R, Colao A. Metabolic syndrome in the era of COVID-19 outbreak: impact of lockdown on cardiometabolic health. J Endocrinol Invest. 2021 Dec;44(12):2845-2847. doi: 10.1007/s40618-021-01563-y. Epub 2021 May 26.
- Bellastella G, Maiorino MI, Esposito K. Endocrine complications of COVID-19: what happens to the thyroid and adrenal glands? J Endocrinol Invest. 2020 Aug;43(8):1169-1170. doi: 10.1007/s40618-020-01311-8. Epub 2020 Jun 1.
- Carfì A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- D'Alto M, Marra AM, Severino S, Salzano A, Romeo E, De Rosa R, Stagnaro FM, Pagnano G, Verde R, Murino P, Farro A, Ciccarelli G, Vargas M, Fiorentino G, Servillo G, Gentile I, Corcione A, Cittadini A, Naeije R, Golino P. Right ventricular-arterial uncoupling independently predicts survival in COVID-19 ARDS. Crit Care. 2020 Nov 30;24(1):670. doi: 10.1186/s13054-020-03385-5.
- Evans PC, Rainger GE, Mason JC, Guzik TJ, Osto E, Stamataki Z, Neil D, Hoefer IE, Fragiadaki M, Waltenberger J, Weber C, Bochaton-Piallat ML, Bäck M. Endothelial dysfunction in COVID-19: a position paper of the ESC Working Group for Atherosclerosis and Vascular Biology, and the ESC Council of Basic Cardiovascular Science. Cardiovasc Res. 2020 Dec 1;116(14):2177-2184. doi: 10.1093/cvr/cvaa230. Review.
- Fabbrocini G, Vastarella M, Nappa P, Annunziata MC, Camela E, Greco V, Gaudiello F, Alessio M, Pierri L, Catzola A, Guarino A. A new dermoscopic pattern for chilblain-COVID-19-like skin lesions in adolescents. JAAD Case Rep. 2020 Dec;6(12):1271-1274. doi: 10.1016/j.jdcr.2020.09.024. Epub 2020 Oct 1.
- Isidori AM, Arnaldi G, Boscaro M, Falorni A, Giordano C, Giordano R, Pivonello R, Pofi R, Hasenmajer V, Venneri MA, Sbardella E, Simeoli C, Scaroni C, Lenzi A. COVID-19 infection and glucocorticoids: update from the Italian Society of Endocrinology Expert Opinion on steroid replacement in adrenal insufficiency. J Endocrinol Invest. 2020 Aug;43(8):1141-1147. doi: 10.1007/s40618-020-01266-w. Epub 2020 Apr 25. Review.
- Muscogiuri G, Barrea L, Savastano S, Colao A. Nutritional recommendations for CoVID-19 quarantine. Eur J Clin Nutr. 2020 Jun;74(6):850-851. doi: 10.1038/s41430-020-0635-2. Epub 2020 Apr 14. Review.
- Muscogiuri G, Pugliese G, Barrea L, Savastano S, Colao A. Commentary: Obesity: The "Achilles heel" for COVID-19? Metabolism. 2020 Jul;108:154251. doi: 10.1016/j.metabol.2020.154251. Epub 2020 Apr 27.
- Ocampo-Garza SS, Vastarella M, Nappa P, Cantelli M, Fabbrocini G. Telogen effluvium in the new SARS-CoV-2 era. Int J Dermatol. 2021 Jul;60(7):e265-e266. doi: 10.1111/ijd.15482. Epub 2021 Mar 4.
- Ortelli P, Ferrazzoli D, Sebastianelli L, Engl M, Romanello R, Nardone R, Bonini I, Koch G, Saltuari L, Quartarone A, Oliviero A, Kofler M, Versace V. Neuropsychological and neurophysiological correlates of fatigue in post-acute patients with neurological manifestations of COVID-19: Insights into a challenging symptom. J Neurol Sci. 2021 Jan 15;420:117271. doi: 10.1016/j.jns.2020.117271. Epub 2020 Dec 14.
- Pivonello R, Auriemma RS, Pivonello C, Isidori AM, Corona G, Colao A, Millar RP. Sex Disparities in COVID-19 Severity and Outcome: Are Men Weaker or Women Stronger? Neuroendocrinology. 2021;111(11):1066-1085. doi: 10.1159/000513346. Epub 2020 Nov 26. Review.
- LO-COCO