Clinical trial NCT05046509: The Clinical Manifestations of the Severe Acute Respiratory Syndrome, Coronavirus 2( SARS-Cov-2 ); Not Only Pulmonary
Official title: The Clinical Manifestations of SARS-Cov-2 Disease; Not Only Pulmonary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from outpatients and inpatients files.

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 %)

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who has one or more of the following extrapulmonary clinical manifestations of SARS-CoV-2 .
timeFrame: one year
Secondary outcomes:
measure: The correlations between the number of participants who has extrapulmonary manifestations and the severity grade of SARS-CoV-2.
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Emad arafa, Msc
role: PRINCIPAL_INVESTIGATOR
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