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

19 september 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

199

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Cairo, Egypten
        • Faculty of Medicine Cairo University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Retrospektiv

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Group 1
Duration of COVID-19 symptoms less than 12 days
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
Andra namn:
  • kortikosteroider
  • antikoagulant
  • antibiotikum
  • vitamin c pill
  • zinc pill
Group 2
Duration of COVID-19 symptoms equal or more than 12 days
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
Andra namn:
  • kortikosteroider
  • antikoagulant
  • antibiotikum
  • vitamin c pill
  • zinc pill

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
COVID-19 disease spectrum and duration
Tidsram: 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
Tidsram: july 2020 to june 2020
spectrum of GIT manifestations in COVID-19 patients was investigated
july 2020 to june 2020

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Non-communicable disease and COVID-19
Tidsram: 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
Tidsram: 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
Tidsram: july 2020 to june 2020
The investigators tried to find new Egyptian classification fro COVID-19 disease severity
july 2020 to june 2020

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2020

Primärt slutförande (Faktisk)

15 juli 2020

Avslutad studie (Faktisk)

15 juli 2020

Studieregistreringsdatum

Först inskickad

12 september 2020

Först inskickad som uppfyllde QC-kriterierna

17 september 2020

Första postat (Faktisk)

18 september 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 september 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 september 2020

Senast verifierad

1 september 2020

Mer information

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