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

Covid19 Clinical Trial

Official title:

The Clinical Manifestations of SARS-Cov-2 Disease; Not Only Pulmonary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046509
• Other study ID #: 17101489
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: June 5, 2022

Study information

• Verified date: June 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The current research in this area was retrospective trials; this study is a prospective one. Investigators will perform the extensive recording of extrapulmonary manifestations in adult patients of SARS-CoV-2 and their correlations with the disease severity grades.

Type of the study: a prospective observational study

Study Setting:

Data will be collected from outpatients and inpatients files and a questionnaire.

Sample Size Calculation:

Depending on the average monthly (40-50 cases) and type of the study :

-Investigators will use Steven K. Thompson equation 13 to calculate the size from the next formula

Population size =(752) Sample size = (414) Level of confidence: ( 95%) Error proportion:

(0.05) Probability :(20 %) Study power: (80 %)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: June 5, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients have been confirmed diagnosed with Covid-19 disease by PCR

• Patients aged 18 years and above

Exclusion Criteria:

• Patients aged below 18 years old.

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (17)

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

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. — View Citation

Galván Casas C, Català A, Carretero Hernández G, Rodríguez-Jiménez P, Fernández-Nieto D, Rodríguez-Villa Lario A, Navarro Fernández I, Ruiz-Villaverde R, Falkenhain-López D, Llamas Velasco M, García-Gavín J, Baniandrés O, González-Cruz C, Morillas-Lahuerta V, Cubiró X, Figueras Nart I, Selda-Enriquez G, Romaní J, Fustà-Novell X, Melian-Olivera A, Roncero Riesco M, Burgos-Blasco P, Sola Ortigosa J, Feito Rodriguez M, García-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. — View Citation

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. Epub 2005 Feb 16. — View Citation

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. — View Citation

Lanza K, Perez LG, Costa LB, Cordeiro TM, Palmeira VA, Ribeiro VT, Simões 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. Review. — View Citation

Li J, Gong X, Wang Z, Chen R, Li T, Zeng D, Li M. Clinical features of familial clustering in patients infected with 2019 novel coronavirus in Wuhan, China. Virus Res. 2020 Sep;286:198043. doi: 10.1016/j.virusres.2020.198043. Epub 2020 Jun 2. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Perico L, Benigni A, Remuzzi G. Should COVID-19 Concern Nephrologists? Why and to What Extent? The Emerging Impasse of Angiotensin Blockade. Nephron. 2020;144(5):213-221. doi: 10.1159/000507305. Epub 2020 Mar 23. Review. — View Citation

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. — View Citation

Xiao F, Tang M, Zheng X, Liu Y, Li X, Shan H. Evidence for Gastrointestinal Infection of SARS-CoV-2. Gastroenterology. 2020 May;158(6):1831-1833.e3. doi: 10.1053/j.gastro.2020.02.055. Epub 2020 Mar 3. — View Citation

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. — View Citation

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. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The correlations between the number of participants who has extrapulmonary manifestations and the severity grade of SARS-CoV-2.	These correlations between the number of participants who has one or more of extrapulmonary manifestations and the severity of SARS-CoV-2, will be measured.; There are four severity grades of SARS-CoV-2 according to WHO classifications (mild, moderate, severe and critical)	one year