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COVID-19 Disease Duration and GIT Manifestations. A New Disease Severity Classification. An Egyptian Experience

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04554979
Collaborator
(none)
199
Enrollment
1
Location
1.4
Actual Duration (Months)
137.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study conducted to correlate symptoms not only constitutional and respiratory, but GIT as a principle presentation, with laboratory markers and COVID-19 severe acute respiratory syndrome (SARS-COV2) disease outcomes, as the duration of symptoms varies substantially between patients; the investigators undertook this study to determine the optimal time to predict COVID-19 outcomes based on real-time experience.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydroxychloroquine Pill

Detailed Description

This observational retrospective cohort single center national study was conducted on patients who tested positive COVID-19 infection by the polymerase chain reaction (PCR) of nasopharyngeal sample in the period from first June to the med of July 2020. Patients were recruited from Kasr Al-Aini School of medicine, COVID-19 out-patient clinic, Cairo University hospitals.

The diagnosis and classification of severity of COVID-19 infection were made according to the clinical management of COVID-19, released by the World Health Organization (WHO), mild and moderate case were recruited, the treatment protocol used was according to the Egyptian ministry of health treatment recommendations, which met in part the criteria that was later on published by the national institute of health, Mild and moderate cases once diagnosed by PCR received hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started till result of sputum culture and sensitivity. Steroids were initiated in hypoxic cases that required supplemental oxygen and in cases of persistent symptoms.

Any adult patient (age ≥18 years) suffering from mild or moderate COVID-19 infection was included in this study. While severe cases according to WHO classifications and patients aged less than18 were excluded from the study.

Study Design

Study Type:
Observational
Actual Enrollment :
199 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Corona Virus (COVID-19) Disease Duration and Gastrointestinal Tract (GIT) Manifestations; Can be New Disease Severity Classification. A Pilot Egyptian Single National Center Experience
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Jul 15, 2020
Actual Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Group 1

Duration of COVID-19 symptoms less than 12 days

Drug: Hydroxychloroquine Pill
hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started
Other Names:
  • corticosteroids
  • anticoagulant
  • antibiotic
  • vitamin c pill
  • zinc pill

    		•
    Group 2

    Duration of COVID-19 symptoms equal or more than 12 days

    Drug: Hydroxychloroquine Pill
    hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started
    Other Names:
  • corticosteroids
  • anticoagulant
  • antibiotic
  • vitamin c pill
  • zinc pill

    		•

    Outcome Measures

    Primary Outcome Measures

    1. COVID-19 disease spectrum and duration [july 2020 to june 2020]

      The investigators tried to correlate disease severity with disease duration

    2. GIT manifestations among COVID-19 patients [july 2020 to june 2020]

      spectrum of GIT manifestations in COVID-19 patients was investigated

    Secondary Outcome Measures

    1. Non-communicable disease and COVID-19 [july 2020 to june 2020]

      The link between non-communicable disease (including diabetes, hypertension and Hypercholesterolemia) severity and COVID-19 prognosis

    2. Seasonal change and COVID-19 [july 2020 to june 2020]

      the investigators studied the Impact of weather climate on COVID-19 presentations (higher incidence of diarrhea in COVID-19 patients in summer) and outcomes

    3. Possible region specific classification for COVID-19 disease [july 2020 to june 2020]

      The investigators tried to find new Egyptian classification fro COVID-19 disease severity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Mild and moderate COVID-19 patients:
    Exclusion Criteria:

    • Age less than 18 years

    • Severe COVID-19 patients: with dyspnea, hypoxia, or >50 percent lung involvement on imaging within 24 to 48 hours

    • Critical COVID-19 patients: with respiratory failure, shock, or multiorgan dysfunction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Mona M Hegazy, MD, Professor of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
    • Study Director: Ahmed M Abdul Ghani, MD, Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
    • Study Chair: Rania M Lithy, MD, Lecturer of Endemic medicine and hepatogastroenterology. Faculty of medicine Cairo University
    • Study Chair: Hoda M abdel-Hamid, MD, Lecturer of Respiratory medicine. Faculty of medicine Cairo University
    • Study Chair: Mahmoud Wahba, MD, Lecturer of Internal Medicine Division of Gastroenterology, Kasr Alainy . Faculty of Medicine, Cairo University
    • Study Chair: Omar Ashoush, MD, Lecturer of Internal Medicine Hepatology & gastroenterology Unit. Faculty of medicine Cairo University
    • Study Chair: Mohamed Tharwat Hegazy, MD, Lecturer of Internal Medicine Department, Rheumatology and Clinical Immunology unit, Faculty of Medicine, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mona Hegazy, Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04554979
    Other Study ID Numbers:
    • 1004
    First Posted:
    Sep 18, 2020
    Last Update Posted:
    Sep 22, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mona Hegazy, Professor of Internal Medicine Hepatology & gastroenterology Unit Faculty of medicine, Cairo University
    COVID-19 disease outcomes and duration
    GIT manifestations
    Diarrhea
    Additional relevant MeSH terms:
    COVID-19
    Diarrhea
    Anti-Bacterial Agents
    Hydroxychloroquine
    Anticoagulants

    Study Results

    No Results Posted as of Sep 22, 2020