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

September 19, 2020 updated by: Mona Hegazy, Cairo University

Corona Virus (COVID-19) Disease Duration and Gastrointestinal Tract (GIT) Manifestations; Can be New Disease Severity Classification. A Pilot Egyptian Single National Center 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 disease spectrum and duration
Time Frame: july 2020 to june 2020
The investigators tried to correlate disease severity with disease duration
july 2020 to june 2020
GIT manifestations among COVID-19 patients
Time Frame: july 2020 to june 2020
spectrum of GIT manifestations in COVID-19 patients was investigated
july 2020 to june 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
july 2020 to june 2020
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
july 2020 to june 2020
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
july 2020 to june 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

July 15, 2020

Study Completion (Actual)

July 15, 2020

Study Registration Dates

First Submitted

September 12, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 19, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Hydroxychloroquine Pill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe