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NCT05185700 Clinical Trial

Symptoms ,Signs and Complications That Appear After Infection With Covid 19 Virus

COVID-19 Clinical Trial

Official title:
Post Covid 19 Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05185700
Other study ID # post covid 19 syndrome
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date December 1, 2023

Study information
Verified date January 2022
Source Assiut University
Contact Mohamed Kl Mohamed, phd
Phone 01098989377
Email mkdarwish90@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Raise awareness for persistent post-COVID syndrome (PPCS). 2. Rising tide of physical and psychological disabilities that have been described in post-COVID patients.

Description:

Since SARS-CoV-2 infection was recognised in late 2019, the academic and clinical emphasis has been on respiratory manifestations . Post-COVID syndrome appears to be a multisystem disease, occurring even after a relatively mild acute illness. Increasing evidence exists for direct multiorgan effects, and indirect effects on other organ systems and disease processes, such as cardiovascular diseases and cancers, through changes in healthcare delivery and patient behaviors . So, the long term effects of covid-19 on individuals and health systems are becoming clear, investigation across organ systems is urgently needed. Long covid, or post-covid syndrome, is not one condition, and is defined by the National Institute for Health and Care Excellence (NICE) as "signs and symptoms that develop during or after an infection consistent with covid-19 which continue for more than 12 weeks and are not explained by an alternative diagnosis . NICE guidelines recommend referral to post-covid syndrome assessment clinics if post covid symptoms persist for 6-12 weeks . Pre-existing conditions and risk factors are predictors of acute covid-19 outcomes (such as admission to the intensive care unit and mortality, but the epidemiology of postcovid syndrome has been less well defined . Because of the unclear medium and long term pathophysiology across organ systems. When post-covid syndrome clinics are established, characterization of the epidemiology of the disease will help with appropriate diagnosis, care, public health interventions and policy, and resource planning. So, further research is highly indicated.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient diagnosed as covid-19. - Presence of post covid-19 symptoms. Exclusion Criteria: - Patient refusal. - Patient less than 18 years.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• post covid 19 symtoms
observation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (9)

Alqahtani SA, Schattenberg JM. Liver injury in COVID-19: The current evidence. United European Gastroenterol J. 2020 Jun;8(5):509-519. doi: 10.1177/2050640620924157. Review. — View Citation

Ball S, Banerjee A, Berry C, Boyle JR, Bray B, Bradlow W, Chaudhry A, Crawley R, Danesh J, Denniston A, Falter F, Figueroa JD, Hall C, Hemingway H, Jefferson E, Johnson T, King G, Lee KK, McKean P, Mason S, Mills NL, Pearson E, Pirmohamed M, Poon MTC, Priedon R, Shah A, Sofat R, Sterne JAC, Strachan FE, Sudlow CLM, Szarka Z, Whiteley W, Wyatt M; CVD-COVID-UK Consortium. Monitoring indirect impact of COVID-19 pandemic on services for cardiovascular diseases in the UK. Heart. 2020 Dec;106(24):1890-1897. doi: 10.1136/heartjnl-2020-317870. Epub 2020 Oct 5. — View Citation

Farouk SS, Fiaccadori E, Cravedi P, Campbell KN. COVID-19 and the kidney: what we think we know so far and what we don't. J Nephrol. 2020 Dec;33(6):1213-1218. doi: 10.1007/s40620-020-00789-y. Epub 2020 Jul 20. Review. — View Citation

Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. Management of post-acute covid-19 in primary care. BMJ. 2020 Aug 11;370:m3026. doi: 10.1136/bmj.m3026. — View Citation

Katsoulis M, Gomes M, Lai AG, Henry A, Denaxas S, Lagiou P, Nafilyan V, Humberstone B, Banerjee A, Hemingway H, Lumbers RT. Estimating the Effect of Reduced Attendance at Emergency Departments for Suspected Cardiac Conditions on Cardiac Mortality During the COVID-19 Pandemic. Circ Cardiovasc Qual Outcomes. 2021 Jan;14(1):e007085. doi: 10.1161/CIRCOUTCOMES.120.007085. Epub 2020 Dec 20. — View Citation

Lai AG, Pasea L, Banerjee A, Hall G, Denaxas S, Chang WH, Katsoulis M, Williams B, Pillay D, Noursadeghi M, Linch D, Hughes D, Forster MD, Turnbull C, Fitzpatrick NK, Boyd K, Foster GR, Enver T, Nafilyan V, Humberstone B, Neal RD, Cooper M, Jones M, Pritchard-Jones K, Sullivan R, Davie C, Lawler M, Hemingway H. Estimated impact of the COVID-19 pandemic on cancer services and excess 1-year mortality in people with cancer and multimorbidity: near real-time data on cancer care, cancer deaths and a population-based cohort study. BMJ Open. 2020 Nov 17;10(11):e043828. doi: 10.1136/bmjopen-2020-043828. — View Citation

Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557. Erratum in: JAMA Cardiol. 2020 Nov 1;5(11):1308. — View Citation

Somasundaram NP, Ranathunga I, Ratnasamy V, Wijewickrama PSA, Dissanayake HA, Yogendranathan N, Gamage KKK, de Silva NL, Sumanatilleke M, Katulanda P, Grossman AB. The Impact of SARS-Cov-2 Virus Infection on the Endocrine System. J Endocr Soc. 2020 Jul 2;4(8):bvaa082. doi: 10.1210/jendso/bvaa082. eCollection 2020 Aug 1. Review. — View Citation

Tabary M, Khanmohammadi S, Araghi F, Dadkhahfar S, Tavangar SM. Pathologic features of COVID-19: A concise review. Pathol Res Pract. 2020 Sep;216(9):153097. doi: 10.1016/j.prp.2020.153097. Epub 2020 Jul 4. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Identifying post covid -19 respiratory manifestations. detection of respiratory symptoms and signs appears within 6 months after infection with covid 19 1 year
Secondary identifying other post covid -19 manifestations. detection of extra respiratory manifestions of covid 19 infection to improve outcome of post covid 19 patients 1 year
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