The Clinical Manifestations of the Severe Acute Respiratory Syndrome, Coronavirus 2( SARS-Cov-2 ); Not Only Pulmonary

NCT05046509 | Completed

• 1 other identifier: 17101489
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective observational study to identify different extrapulmonary clinical manifestations of SARS-CoV-2 and its correlations with the disease severity grades.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of participants who has one or more of the following extrapulmonary clinical manifestations of SARS-CoV-2 .

  Cardiovascular : * Coronary Artery Disease * Infarction (type 2) * Myocarditis * Arrhythmia * Cardiogenic shock * Heart failure Gastrointestinal : * Anorexia * Diarrhea * Bleeding * Digestive symptoms * Abnormal liver tests Neurological : * Headache * Impaired consciousness * acute ischemic stroke * Ataxia * Dizziness * Seizure * Taste impairment * Smell impairment * Vision impairment * Viral encephalitis * Depression Endocrinal: * Hypoglycemia * Ketoacidosis * Hyperglycemia * Thyrotoxicosis * Secondary Adrenal Insufficiency Hematological: * Leukocytosis * Leukopenia * Thrombocytopenia * Anemia * Lymphocytosis * D-dimer * Lactate dehydrogenase * Ferritin Renal : * Albuminuria * Hematuria * Blood urea nitrogen * Acute kidney injury Ophthalmologic : -Conjunctivitis Dermatologic : * Papulovesicular rash * Rosacea * Dryness * Erythema * Urticaria * Maculopapular exanthem morbilliform

  one year

Secondary Outcomes (1)

• The correlations between the number of participants who has extrapulmonary manifestations and the severity grade of SARS-CoV-2.

  one year

Study Arms (1)

COVID_Patients

* Patients have been confirmed diagnosed with Covid-19 disease by PCR * Patients aged 18 years and above

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected from outpatients and inpatients files.

You may qualify if:

• Patients have been confirmed diagnosed with Covid-19 disease by PCR
• Patients aged 18 years and above

You may not qualify if:

• Patients aged below 18 years old.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 741111, Egypt

Location

Related Publications (17)

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  PMID: 32142773 BACKGROUND

• Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.

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• Zhu L, She ZG, Cheng X, Qin JJ, Zhang XJ, Cai J, Lei F, Wang H, Xie J, Wang W, Li H, Zhang P, Song X, Chen X, Xiang M, Zhang C, Bai L, Xiang D, Chen MM, Liu Y, Yan Y, Liu M, Mao W, Zou J, Liu L, Chen G, Luo P, Xiao B, Zhang C, Zhang Z, Lu Z, Wang J, Lu H, Xia X, Wang D, Liao X, Peng G, Ye P, Yang J, Yuan Y, Huang X, Guo J, Zhang BH, Li H. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metab. 2020 Jun 2;31(6):1068-1077.e3. doi: 10.1016/j.cmet.2020.04.021. Epub 2020 May 1.

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• Patel S, Rauf A, Khan H, Abu-Izneid T. Renin-angiotensin-aldosterone (RAAS): The ubiquitous system for homeostasis and pathologies. Biomed Pharmacother. 2017 Oct;94:317-325. doi: 10.1016/j.biopha.2017.07.091. Epub 2017 Jul 31.

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• Lanza K, Perez LG, Costa LB, Cordeiro TM, Palmeira VA, Ribeiro VT, Simoes E Silva AC. Covid-19: the renin-angiotensin system imbalance hypothesis. Clin Sci (Lond). 2020 Jun 12;134(11):1259-1264. doi: 10.1042/CS20200492.

  PMID: 32507883 BACKGROUND

• Gembardt F, Sterner-Kock A, Imboden H, Spalteholz M, Reibitz F, Schultheiss HP, Siems WE, Walther T. Organ-specific distribution of ACE2 mRNA and correlating peptidase activity in rodents. Peptides. 2005 Jul;26(7):1270-7. doi: 10.1016/j.peptides.2005.01.009. Epub 2005 Feb 16.

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• Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, Li T, Chen Q. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci. 2020 Feb 24;12(1):8. doi: 10.1038/s41368-020-0074-x.

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• Zou X, Chen K, Zou J, Han P, Hao J, Han Z. Single-cell RNA-seq data analysis on the receptor ACE2 expression reveals the potential risk of different human organs vulnerable to 2019-nCoV infection. Front Med. 2020 Apr;14(2):185-192. doi: 10.1007/s11684-020-0754-0. Epub 2020 Mar 12.

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• Martinez-Rojas MA, Vega-Vega O, Bobadilla NA. Is the kidney a target of SARS-CoV-2? Am J Physiol Renal Physiol. 2020 Jun 1;318(6):F1454-F1462. doi: 10.1152/ajprenal.00160.2020. Epub 2020 May 15.

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• Carsetti R, Quintarelli C, Quinti I, Piano Mortari E, Zumla A, Ippolito G, Locatelli F. The immune system of children: the key to understanding SARS-CoV-2 susceptibility? Lancet Child Adolesc Health. 2020 Jun;4(6):414-416. doi: 10.1016/S2352-4642(20)30135-8. Epub 2020 May 6. No abstract available.

  PMID: 32458804 BACKGROUND

• [13] Steven K Thomson sampling 2012 third edition P 59-60

  BACKGROUND

• Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.

  PMID: 32171076 BACKGROUND

• Hirsch JS, Ng JH, Ross DW, Sharma P, Shah HH, Barnett RL, Hazzan AD, Fishbane S, Jhaveri KD; Northwell COVID-19 Research Consortium; Northwell Nephrology COVID-19 Research Consortium. Acute kidney injury in patients hospitalized with COVID-19. Kidney Int. 2020 Jul;98(1):209-218. doi: 10.1016/j.kint.2020.05.006. Epub 2020 May 16.

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• Wu P, Duan F, Luo C, Liu Q, Qu X, Liang L, Wu K. Characteristics of Ocular Findings of Patients With Coronavirus Disease 2019 (COVID-19) in Hubei Province, China. JAMA Ophthalmol. 2020 May 1;138(5):575-578. doi: 10.1001/jamaophthalmol.2020.1291.

  PMID: 32232433 BACKGROUND

• Galvan Casas C, Catala A, Carretero Hernandez G, Rodriguez-Jimenez P, Fernandez-Nieto D, Rodriguez-Villa Lario A, Navarro Fernandez I, Ruiz-Villaverde R, Falkenhain-Lopez D, Llamas Velasco M, Garcia-Gavin J, Baniandres O, Gonzalez-Cruz C, Morillas-Lahuerta V, Cubiro X, Figueras Nart I, Selda-Enriquez G, Romani J, Fusta-Novell X, Melian-Olivera A, Roncero Riesco M, Burgos-Blasco P, Sola Ortigosa J, Feito Rodriguez M, Garcia-Doval I. Classification of the cutaneous manifestations of COVID-19: a rapid prospective nationwide consensus study in Spain with 375 cases. Br J Dermatol. 2020 Jul;183(1):71-77. doi: 10.1111/bjd.19163. Epub 2020 Jun 10.

  PMID: 32348545 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Emad arafa, Msc

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Allergist and Immunologist

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 16, 2021
• Study Start: April 1, 2021
• Primary Completion: June 5, 2022
• Study Completion: June 5, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

EG (1)