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Completed

NCT Number: NCT04554979

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hydroxychloroquine Pill

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 18, 2020
Registry last updated
Sep 22, 2020

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.

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