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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04554979
Recruitment Status : Completed
First Posted : September 18, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Mona Hegazy, Cairo University

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
Covid19 Diarrhea 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.

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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 : June 1, 2020
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Group/Cohort 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




Primary Outcome Measures :
  1. COVID-19 disease spectrum and duration [ Time Frame: july 2020 to june 2020 ]
    The investigators tried to correlate disease severity with disease duration

  2. GIT manifestations among COVID-19 patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: july 2020 to june 2020 ]
    The investigators tried to find new Egyptian classification fro COVID-19 disease severity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients was recruited from COVID19 out-patient clinic, Cairo University hospitals. Severity Classification made according to the WHO (13) and Egyptian ministry of health treatment recommendations (14) Clinical data was collected including patient demographics (age, gender, weight and height, body mass index, comorbid conditions (e.g.diabetes mellitus, chronic pulmonary disease), vital signs. Clinical symptoms were recorded using yes/no checklist about constitutional symptoms, respiratory symptoms, loss of taste, loss of smell and gastrointestinal symptoms.The patients were followed up daily; by telehealth through phone calls and commercial video chat platforms, till symptoms offset. Laboratory assessment was collected within 24 hours of symptoms onset (complete blood picture, kidney and liver biochemistry, random blood sugar, serum C-reactive protein, D-dimer, ferritin, lipid profile, and lactate dehydrogenase). CT chest was performed and its result was recorded
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554979


Locations
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Egypt
Faculty of Medicine Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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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
Publications:
1.World Health Organization. Novel coronavirus (2019-nCoV): situation report-40. Available at: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200229-sitrep-40-covid-19.pdf. Accessed 29 February 2020.
8. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. [published online ahead of print, 2020 Feb 7]. JAMA 2020;e201585. doi:10.1001/jama.2020.1585
13. World Health Organization. Clinical management of COVID-19: interim guidance. 2020, p.62.
14. National Egyptian Institutes of Health. Coronavirus Disease (COVID-19) Treatment Guidelines. 2020.

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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: September 18, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mona Hegazy, Cairo University:
COVID-19 disease outcomes and duration
GIT manifestations
Diarrhea
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Hydroxychloroquine
Anticoagulants
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents