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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05046509

Enrollment

445

Registered

2021-09-16

Start date

2021-04-01

Completion date

2022-06-05

Last updated

2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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 %)

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Egypt

Outcome results