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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University Hospital

Asyut, 741111, Egypt

About this study

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 %)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 16, 2021
Registry last updated: Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed