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

Completed

• Conditions: Covid19

• Registration Number: NCT05046509
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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 %)

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-16
• Status Verified: 2022-06
• Primary Completion: 2022-06-05
• Study Completion: 2022-06-05
• Last Update Submitted: 2022-06-05
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who has one or more of the following extrapulmonary clinical manifestations of SARS-CoV-2 .	one year	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

Secondary Outcome Measures

Name	Time	Method
The correlations between the number of participants who has extrapulmonary manifestations and the severity grade of SARS-CoV-2.	one year	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)

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt