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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT05046509
Collaborator
(none)
445
Enrollment
1
Location
14.1
Actual Duration (Months)
31.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    445 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Clinical Manifestations of SARS-Cov-2 Disease; Not Only Pulmonary
    Actual Study Start Date :
    Apr 1, 2021
    Actual Primary Completion Date :
    Jun 5, 2022
    Actual Study Completion Date :
    Jun 5, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    COVID_Patients

    Patients have been confirmed diagnosed with Covid-19 disease by PCR Patients aged 18 years and above

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Hospital Assiut Egypt 741111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Emad arafa, Msc, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Emad eldin arafa Aly, Allergist and Immunologist, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05046509
    Other Study ID Numbers:
    • 17101489
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 8, 2022